Kristoffersen et al.

Trials (2016) 17:593

DOI 10.1186/s13063-016-1730-5

STUDY PROTOCOL Open Access

Early skin-to-skin contact or incubator

for very preterm infants: study protocol
for a randomized controlled trial
Laila Kristoffersen1,2*, Ragnhild Støen1,2, Hilde Rygh1, Margunn Sognnæs3, Turid Follestad4, Hilde S. Mohn5,6,
Ingrid Nissen1,6 and Håkon Bergseng1,2

Abstract
Background: Skin-to-skin care immediately following delivery is a common practice for term infants and has been
shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007, the
use of skin-to-skin care has been practiced for preterm infants from 32 weeks of gestation in the delivery room at
St. Olav’s University Hospital. In the present study we aim to investigate whether skin-to-skin care following delivery
is safe, and how it affects early and late outcomes compared to standard care for very preterm infants.
Methods/Design: A randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm
infants born at gestational age 280–316 weeks with birth weight >1000 grams. Infants with severe congenital
malformations or need of intubation in the delivery room are excluded. A detailed checklist and a flowchart were
prepared for the study, and all involved professionals (neonatologists, neonatal nurses, obstetricians, anesthesiologists,
midwives) participated in medical simulation training prior to study start on February 1, 2014. A consultant in
neonatology and a neonatal nurse are present at all deliveries. Infants with birth weight <1500 grams receive
an intravenous line with glucose, amino acids, and caffeine citrate in the delivery room. Infants with gestational
age <30 weeks are routinely put on continuous positive airway pressure (CPAP). After initial stabilization, infants are
randomized to skin-to-skin care or are transferred to the nursery in an incubator. Primary outcome is cognitive
development at 2 years measured with the Bayley Scales of Infant Development, Third Edition. Secondary outcomes
are safety defined as hypothermia, respiratory failure, and/or cardiopulmonary resuscitation, physiological stability
after birth and motor, language and cognitive development at 1 year for the child, and mental health measured
with the State-Trait Anxiety Inventory (STAI) at discharge, and at 3 months and 2 years after expected date of
delivery for the mothers.
Discussion: The study may have important implications for the initial care for very preterm infants after delivery
and increase our understanding of how early skin-to-skin care affects preterm infants and their mothers.
Trial registration: ClinicalTrials, NCT02024854. Registered on 19 December 2013.
Keywords: Very preterm infants, Early skin-to-skin, Kangaroo mother care, Neonatal intensive care unit

* Correspondence: Laila.kristoffersen@ntnu.no
1
Department of Pediatrics, St. Olav’s University Hospital, Trondheim, Norway
2
Department of Laboratory Medicine, Children’s and Women’s Health,
Norwegian University of Science and Technology, NTNU, Trondheim, Norway
Full list of author information is available at the end of the article

© The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Kristoffersen et al. Trials (2016) 17:593 Page 2 of 9

Background available only in the NICU. Breathing support, need of sur-

Worldwide, 15 million infants are born preterm annually factant, intravenous access, and monitoring equipment are
[1], and preterm birth is one of the largest direct causes needed in a large proportion of infants below 32 weeks. To
of neonatal mortality and morbidity [2]. Compared to combine medical interventions with early SSC, a trained
full-term infants, preterm infants are at increased risk of team and formalized guidelines are required to ensure the
neurodevelopmental impairments [3–5]. This also in- medical safety of the infant. Specific challenges arise with
cludes lower self-esteem, social relations, and quality of early SSC in the OR after cesarean section (C-section).
life in adulthood [6]. There is growing evidence that Moving treatment and medical procedures from the
mental and behavioral problems in children born pre- NICU into the DR and OR requires cooperation across
term last into adulthood [7–13]. These societal and specialties and departments. Pediatricians and neonatal
medical consequences of preterm births have led to a nurses have to work outside their familiar NICU envir-
growing interest in developmental care models to onment, while gynecologists, midwives, anesthesiolo-
optimize neurodevelopmental outcomes. Different ap- gists, nurse specialists in anesthesia, and operating room
proaches aiming to support infants and parents have nurses have to adjust their work and procedures to the
been established in neonatal intensive care units presence of the preterm infant on the mother’s chest.
(NICUs) in recent years, and some of these early inter- In the present study we aim to investigate whether SSC
vention programs seem to have a positive effect on long- following delivery is safe, and how it affects early and late
term function up to preschool age [5, 14, 15]. The first outcomes compared to standard care for preterm infants
hours after birth represent a sensitive period for the very born at GA 280–316 weeks.
low birthweight infant (VLBW), and mothers who see The purpose of this article is to present the study
their infant within 3 hours after birth are likely to estab- design and a description of the intervention, as well as
lish a more secure attachment to the infant compared to provide a detailed outline of how the intervention was
those who do not see their infant within 3 hours [16]. planned and implemented in a multidisciplinary team.
Parents are increasingly acknowledged as primary care- Schedule of enrolment, interventions, and assessment
givers for their preterm-born infant; despite the need for are outlined in Table 1.
intensive care, most NICUs try to facilitate early parent-
infant bonding. Education of parents to understand Aims
subtle signs and signals from their tiny, preterm-born Primary aim
infants is considered an investment in an optimal home To study the effect of early SSC versus standard care
environment for the child. From being forced to separate (SC) for very preterm infants (280–316 weeks) on cogni-
from their newborn infant due to restrictions of visiting tive scores at 2 years corrected age, measured with the
hours in NICUs, parents are now generally encouraged Bayley Scales of Infant Development, Third Edition (Bay-
to stay with their infant as much as possible [17, 18]. ley-III).
Kangaroo care (KC) [19], family-centered care (FCC)
[20], Newborn Individualized Development Care and Secondary aims
Assessment Program (NIDCAP) [21, 22], and a variety
of early intervention programs emphasize the import-  To assess safety of the intervention by measuring
ance of establishing early parent-infant interaction to incidence of hypothermia (temperature <36 °C) or
support an optimal development [23–25]. Facilitating respiratory failure during the first 2 hours of life.
early skin-to-skin care (SSC) is one way of supporting  To estimate the effect of the intervention on
early parent-infant bonding and is also associated with complications to prematurity (intraventricular
improved physiological stability [26, 27] and decreased hemorrhage (IVH) or periventricular leukomalacia
cortisol reactivity [28]. In addition, a recent World (PVL), seizures, necrotizing enterocolitis (NEC),
Health Organization (WHO) guideline on interventions treatment for persistent ductus arteriosus (PDA),
to improve outcomes for preterm infants, strongly rec- and bronchopulmonary dysplasia (BPD)).
ommends early SSC as thermal care for preterm infants  To estimate the effect of the intervention on
weighing <2000 grams [29]. physiological stability during the first 24 hours.
Skin-to-skin care in the delivery room (DR) has been  To estimate the effect of the intervention on
studied for preterm infants from 32 weeks of gestation maternal mental health at discharge from the NICU
[30]. However, to the best of our knowledge, SSC in the and when the child’s corrected age is 3 months and
DR and the operating room (OR) has not been systematic- again at the corrected age of 2 years by using the
ally investigated for infants born at gestational age (GA) State-Trait Anxiety Inventory (STAI).
<32 weeks. Obvious obstacles to do so would be the need  To investigate if the intervention affects the fidgety
for medical equipment and competent personnel, usually type of general movements and detailed aspects of
Kristoffersen et al. Trials (2016) 17:593 Page 3 of 9

Table 1 Schedule of enrolment, interventions, and assessment

Activity/assessment Staff member Approximate time to Before t0 t1 t2 t3 t4 t5 t6 t7 t8 t9 t10 t11 t12 t13 t14
complete delivery
Informed consent Neonatal nurse/ 15 minutes x
physician
Inclusion/exclusion form Neonatal nurse 5 minutes x
Randomization sealed envelopes Neonatal nurse 1 minute x
Heart rate Neonatal nurse 30 sec x x x x x
Respiration rate Neonatal nurse 30 sec x x x x x
Oxygen saturation Neonatal nurse 30 sec x x x x x
Body temperature Neonatal nurse 30 sec x x x x x x
1 1
Blood glucose Neonatal nurse 5 minutes x x x x
Blood pressure Neonatal nurse 5 minutes x x x
Maternal anxiety (STAI) Study coordinator 15 minutes x x x
Ages & Stages Questionnaire Study coordinator 15 minutes x x
General movement (GMA) Study coordinator 5 minutes x
Bayley Scale of Infant and Toddler Occupational 60 minutes x x
Development III therapist
X1 = the blood glucose is measured at either 90 or 120 minutes
t0 = During stabilization
t1 = After initial stabilization
t2 = 15 minutes after birth
t3 = 30 minutes after birth
t4 = 60 minutes after birth
t5 = 120 minutes after birth
t6 = First 24 hour (hourly)
t7 = Approximately 12 hours after birth
t8 = 10 hours after birth
t9 = 18 hours after birth
t10 = Approximately 24 hours after birth
t11 = At discharge
t12 = 3 months corrected age
t13 = 1 year corrected age
t14 = 2 years corrected age

the early motor repertoire at the corrected age of Approximately 50 infants with GA <32 weeks are born
3 months, using the General Movement Assessment every year at St. Olav’s Hospital.
(GMA) and the Assessment of Motor Repertoire – 2 The NICU at St. Olav’s Hospital has 21 beds, with seven
to 5 months (AMR). beds for intensive care, seven intermediate, and seven in a
 To estimate the effect of the intervention on step-down unit. Altogether, there are 107 nurses (many
neurodevelopmental outcomes including cognition, part-time) and six consultants working in the NICU. The
language, and motor function at the corrected age maternity ward has two sections with seven delivery
of 1 year, and language and motor function at the rooms each and about 120 midwives employed.
corrected age of 2 years assessed with Bayley-III. Delivery rooms are in the same building as the NICU,
 To investigate the effect of the intervention on social but on separate floors (fifth and second floor, respectively).
and emotional competence at the corrected age of The operating room and the postoperative ward are in the
3 months and at 2 years with the Ages & Stages same building and at the same floor as the NICU.
Questionnaire - Social-Emotional
Study design
Methods/Design The study is designed as an RCT with randomization to
Project context skin-to-skin care (SSC) or standard care (SC) in an incu-
The study is currently being carried out at St. Olav’s bator after delivery.
University Hospital in Trondheim. Trondheim is the
third largest city in Norway, and St. Olav’s Hospital Study population
serves a population of almost 446,000 and is a tertiary Singleton and twin preterm infants with GA 280–316 and
care center for preterm infants <30 weeks of gestation. a BW >1000 grams in a stable medical condition delivered
Kristoffersen et al. Trials (2016) 17:593 Page 4 of 9

either vaginally or by C-section are candidates for inclu- taken from the umbilical artery before cord clamping,
sion. Twins are randomized to the same intervention. In- while blood for hemoglobin, leukocytes, thrombocytes,
fants with severe malformations not compatible with life, C-reactive protein (CRP) and blood typing is sampled
or requiring surgery within hours to days after birth (e.g. after the cord clamping.
esophageal atresia, abdominal wall defects or neural tube After the initial stabilization, the infant is treated and
defects), will be excluded. evaluated according to checkpoint 1 on the checklist,
Infants who need intubation and mechanical ventila- and eligibility is decided by the consultant (Fig. 1). In-
tion, or CPAP with more than 40% oxygen to maintain a fants randomized to standard care are transferred to the
saturation above 90% at 10 minutes of age, are excluded. NICU in an incubator after stabilization. The father will
Mothers have to be awake (not under general anesthesia) usually follow the newborn to the NICU, while the
during C-section. mother will come as soon as possible after delivery.
All infants with a BW <1500 g, irrespective of
Intervention randomization, are given parenteral nutrition (glucose and
For all infants of eligible women, cord milking is advised amino acids) after the initial stabilization. Infants with a
immediately following delivery and before the infant is GA <30 weeks receive CPAP, infants ≥30 weeks get CPAP
placed on the resuscitation unit. Predefined blood sam- if clinically indicated. If necessary, surfactant can be
ples are taken from the umbilical cord. Blood gas is administered via a thin catheter in the trachea during

Fig. 1 Flowchart illustrating the first 2 hours after birth

Kristoffersen et al. Trials (2016) 17:593 Page 5 of 9

spontaneous breathing on CPAP (“surfactant without outside the resource team acted as a mother in labor
intubation” (SWI) if oxygen requirement exceeds 35% on during all training days.
CPAP and/or the infant has signs of moderate to severe
respiratory distress. After the infant is stabilized in Outcomes measures
skin-to-skin position on the mother’s chest (SSC) or in Primary outcome
a closed incubator and transferred to the NICU (SC), Bayley Scales of Infant and Toddler Development,
the infant is evaluated again (checkpoint 2) according Third Edition (Bayley-III) The Bayley-III is a screening
to the checklist (Fig. 1). test that includes assessment of cognition, language (re-
Infants in the intervention group are offered SSC up ceptive and expressive), and motor function (gross and
to 2 hours after delivery – in the delivery room after va- fine) in infants and young children from 0 to 42 months
ginal delivery, or in the recovery room after C-section. A and provides a measurable and validated cognitive quo-
consultant and a neonatal nurse are responsible for the tient [33]. The occupational therapist conducting the
infant, while a midwife takes care of the mother. After Bayley for ages 1 and 2 years are unaware of the inter-
C-section, the same personnel from the NICU and from vention group.
the maternity ward are present in addition to specialist
nurses from the postoperative ward. When the infant is Secondary outcomes
stabilized on the mother’s chest, the consultant can leave Safety Hypothermia (<36 °C), respiratory failure requir-
the DR or postoperative ward in agreement with the ing acute intubation, and/or cardiopulmonary resuscita-
neonatal nurse in charge. The consultant is nearby and tion (CPR).
easily reachable by telephone.
Further treatment during the hospitalization does not Physiological stability Physiological variables are re-
differ between groups. According to the unit’s guidelines, corded during the first 24 hours (Table 1).
both mothers and fathers have unrestricted access to the
NICU and are encouraged to have as much skin-to-skin State-Trait Anxiety Inventory (STAI) Maternal anxiety
contact with their preterm infant as possible. is measured with STAI Form Y [34]. STAI measures
state and trait anxiety [35]; the mothers answer this
Simulation-based training (SBT) questionnaire before the infants are discharged from the
Simulation-based training (SBT) is effective for medical hospital, and when the child is 3 months and 2 years
education [31], facilitates multidisciplinary training [32], (corrected age). The questionnaire consists of 20 state-
and can be tailored to individual needs with no risk for ments that evaluate how the mother feels ‘at this mo-
human patients. Before study start, simulation-based ment’ and twenty statements that evaluate how the
training was facilitated for five consultants, fifteen neo- mother feels ‘generally’. All items are scored according
natal nurses and ten midwives. One gynecologist, one to a 4-point Likert scale
anesthesiologist, and one operating nurse were observers
during one SBT. The SBT was a collaboration with the General Movement Assessment (GMA) All infants are
Medical Simulation Center (MSC) at St. Olav’s Univer- videotaped at 10–15 weeks post term age (fidgety move-
sity Hospital/NTNU. The instructors from the MSC ments’ period) for the GMA and the AMR. The video
(one pediatrician and one specialist nurse) had formal recordings are performed and classified according to the
European standard instructor training. An in situ sce- Prechtl method [36, 37] by a certified GMA observer
nario, reflecting the complexity of the admittance of a unaware of the intervention group.
very preterm infant, was customized and conducted in
the OR and DR during a total of seven training days. Ages & Stages Questionnaire - Social-Emotional
Prior to the SBT at St. Olav’s Hospital, the teams were (ASQ-SE) The child’s social and emotional competence
informed about the equipment, the environment, and is evaluated using the ASQ-SE at corrected age of
the procedures for the initial stabilization and the inter- 3 months and 2 years [38]. The ASQ-SE comprises 22
vention. Each trainee participated actively in one or two questions that address seven behavioral areas: self regu-
scenarios per training day. Immediately before the sce- lation, compliance, communication, adaptive function-
nario, each team received a case history with informa- ing, autonomy, affect, and interaction with people. The
tion about GA and birth weight, saturation level, heart ASQ-SE is a screening instrument developed for
rate, and the work of breathing. Any change in physio- children aged 3 months to 5 years.
logical parameters was visible on a monitor, and the
team had to act based on the infant’s condition. Each Clinical registration
team comprised two neonatal nurses, a consultant in A case report form (CRF) has been prepared in cooper-
neonatology, and one or two midwives. One person ation with the Unit for Applied Clinical Research at the
Kristoffersen et al. Trials (2016) 17:593 Page 6 of 9

Norwegian University of Science and Technology (NTNU). temperature and positive weight gain. A family is
The CRF is divided into three parts. invited to participate in the home care program if
there are two caregivers at home during the day and
1. On admission and the first 24 hours: at least one of them speaks Norwegian or English.
Background data which are recorded are: mode of
delivery, GA, sex, Apgar scores at 1, 5 and 10 minutes, Sociodemographic information
birthweight, length, head circumference, maternal Information about education, employment (part- or full-
cause of preterm delivery (preeclampsia, breech time) and marital status is collected from the mothers’
position, rupture of membranes, premature medical records.
contractions or infection), fetal cause of preterm
delivery (growth retardation, non-reassuring Consent and enrolment
CTG registration), and antenatal steroids (full Pregnant women admitted to the maternity ward at St.
or incomplete course). Olav’s University Hospital for anticipated preterm deliv-
Observations and interventions which are recorded ery between 280–316 weeks of gestation are eligible. Oral
during the first 24 hours are: oxygen saturation and and written information about the study is provided by a
requirement, mode of breathing support (hourly), pediatrician and/or a neonatal nurse, and written con-
surfactant administration, time of SSC after birth sent is obtained before delivery,
and any cause for interrupted SSC before 120 minutes,
age at the first feed (gavage or oral), any intravenous Randomization and allocation concealment
infusion, transcutaneous carbon dioxide and total The randomization is done after the initial stabilization
amount of enteral and parenteral nutrition given. of the infant (Fig. 1). Infants are stratified by weeks of
Blood pressure is measured once during the first gestation (280–296 and 300–316). The randomization is
120 minutes. conducted using sealed envelopes organized by the Unit
Adverse events: the safety is closely monitored for Applied Clinical Research at the NTNU.
by the consultant and the neonatal nurse present.
It will be registered as an adverse event if body Sample size and statistical analyses
temperature drops <36.0 C° or if the infants Primary analysis: sample size calculations are performed
have signs of any respiratory failure requiring for a two-sample t test for comparing the Bayley Scale of
interventions in addition to an interruption of Infant and Toddler Development, Third Edition, cogni-
SSC and transfer to the NICU for a higher level tive scale between the intervention (SSC) and control
of monitoring and/or respiratory support. (SC) groups at 2 years of corrected age. To obtain a
2. During hospitalization: power of 80% for detecting a difference of 7.5 in mean
Variables recorded are: daily weight, age on removal score, using SD = 15 and significance level α = 0.05, 64
of feeding tube, time in skin-to-skin position every preterm infants are needed in each group. To allow for
day, all nutrition (parenteral and enteral), any insulin withdrawals, the sample size is set to 68 in each group.
given, any surgery, mechanical ventilation (mode Secondary analysis: differences between the SSC and
and duration), CPAP/bilevel positive airway pressure SC groups for continuous variables will be analyzed
(BiPAP) (duration), supplemental oxygen and/or using two-sample t tests, or Mann-Whitney U tests for
ventilator support at 28 postnatal days, 36 and data with non-normal distributions. Categorical variables
40 weeks postmenstrual age (BPD), any sepsis (with will be analyzed by the Pearson chi-square test or Fish-
maximal CRP and duration of antibiotic), cerebral er’s exact test. P values <0.05 are considered statistically
ultrasound and magnetic resonance imaging (MRI) significant. Due consideration of multiple testing will be
results (IVH or PVL), seizures, NEC, treatment for made when interpreting the results. All data will be pre-
PDA and postmenstrual age (PMA) for transfer from sented and analyzed in accordance with the updated
intermediate to the step-down unit in the NICU. CONSORT guidelines for randomized trials [39].
3. At discharge:
Variables recorded are: PMA, weight, length, head Discussion
circumference and mode and type of nutrition. The presentation of the study protocol covering de-
At St. Olav’s Hospital, families living less than sign, outcome measures, sample size calculations, and
30 minutes by car from the hospital are offered procedures of this RCT on early skin-to-skin for very
home care with gavage feeding for infants from preterm infants, is in accordance with the Standard
PMA 34 weeks. Criteria for participation for the Protocol Items: Recommendations For Interventional
infants are: full enteral feeds; no apneas/bradycardias Trials (SPIRIT) 2013 statement for clinical trial proto-
requiring caffeine or monitoring; stable body cols Additional file 1 [40].
Kristoffersen et al. Trials (2016) 17:593 Page 7 of 9

Bayley Scales of Infant and Toddler Development, eligible pregnant women have been admitted to the ma-
Third Edition (Bayley-III) at 2 years of corrected age is ternity ward at St. Olav’s Hospital. A majority of these
chosen as the primary outcome measure. Although did not deliver before 32 weeks of gestation. Up to June,
many interventions in the neonatal period appear to 2016, 27 infants have been included in the study.
have short-term beneficial effects [15, 23, 41, 42], such From January 1, 2017, two other hospitals in Norway
effects seem to disappear over time [15, 43]. The com- will participate in the study: Drammen Hospital, located
plexity of neurodevelopment and the genetic, epigenetic, in the eastern part of Norway, and Kristiansand Hospital
and environmental factors, which may influence the de- in the southern part. Between 30 and 35 infants with
velopment, makes it less likely that a single, short-lasting GA <32 weeks are born every year at each of these
intervention will lead to a change in cognition and/or hospitals. Based on this, the estimated time for end of
behavior after 2 years. Thus, any intervention offered to inclusion will be 2018.
these infants must be followed over time to learn more
about their potential effects or lack of such. Additional file
In order to assess developmental delay in the children
at the corrected age of 3 months and 2 years, the ASQ- Additional file 1: SPIRIT 2013 Checklist: recommended items to address
SE is used [38]. This screening instrument is found to be in a clinical trial protocol and related documents*. (PDF 74 kb)
valid in identifying of social and emotional difficulties in
children [44]. Preterm delivery is associated with mater- Abbreviations
AMR: Assessment of Motor Repertoire; ASQ-SE: Ages & Stages Questionnaire -
nal anxiety and stress [45–47], and the effect of separ- Social-Emotional; Bayley-III: Bayley Scales of Infant and Toddler Development,
ation of the mother and her very preterm infant is not Third Edition; BPD: Bronchopulmonary dysplasia; CPAP: Continuous positive
well studied. We have chosen to assess this aspect by airway pressure; CRF: Case report form; CRP: C-reactive protein; DR: Delivery
room; FFC: Family-centered care; GA: Gestational age; GMA: General Movement
using the STAI, which is validated in a Norwegian popu- Assessment; IVH: Intraventricular hemorrhage; KC: Kangaroo care;
lation and found reliable in terms of assessing anxiety in NEC: Necrotizing enterocolitis; NICU: Neonatal intensive care unit;
women [34]. NIDCAP: Newborn Individualized Developmental Assessment Program;
OR: Operation room; PDA: Persistent ductus arteriosus; PMA: Postmenstrual age;
Lately, there has been a shift toward a more gentle ini- PVL: Periventricular leukomalacia; SBT: Simulation-based training; SC: Standard
tial handling of preterm neonates. This view is well de- care; SSC: Skin-to-skin care; STAI: State-Trait Anxiety Inventory
scribed by Jobe and colleagues, who argue that the
majority of preterm infants need only supportive treat- Acknowledgements
Not applicable.
ment in the transition to the extrauterine life, and not
resuscitation [48, 49]. The main focus of this approach Funding
has, so far, been on early CPAP [50, 51], less invasive Not applicable. The study does not receive any financial support.
ways of surfactant administration [52, 53], avoidance of
Availability of data and materials
early mechanical ventilation [54], and maintenance of Not applicable.
adequate body temperature [55]. In line with this, facili-
tation of early skin-to-skin contact between the preterm Authors’ contributions
infant and the mother could contribute to a more gentle LK is project leader of the study, and contributed significantly to the study
design, data management and collection, ethics considerations, and
adjustment to extrauterine life with improved physio- implementation strategies, and drafted the manuscript. HB significantly
logical stability. The results from this study will have im- contributed to the study design, development of the intervention, outcomes,
portant implications for how we care for very preterm sample size calculation, data collection and management, and made substantive
intellectual contribution in writing, and supervision. RS significantly contributed
infants immediately after delivery. It will also increase to the study design, development of the intervention, outcomes, sample size
our understanding of how early SSC affects very preterm calculation, data collection and management and made substantive intellectual
infants and their mothers. contribution to writing the manuscript. TF contributed significantly to sample
size calculation, statistical analysis proposal, and randomization processes. MS
Those who are conducting the Bayley-III and the helped to develop the concept, study design, and outcomes. HR was involved
GMA will be masked to the intervention group, but not in the study design, data collection, and management. HSM was involved in
the parents and NICU staff caring for the baby in the implementation strategies and study design. IN was involved in development
of the feasibility objectives, and study design. All authors were involved
first 24 hours. Parents in the SSG group may continue in the review of this manuscript and have seen and are in agreement
to have an increased focus on SSC, and this could poten- with the final manuscript.
tially extend the total skin-to-skin time in the NICU.
Competing interests
However, this limitation seems inevitable with the inter- The authors declare that they have no competing interests.
vention in question.
Consent for publication
Trial status Written informed consent was obtained from the patient/participant for
publication of their individual details and accompanying images in this
The study is currently recruiting participants. Since manuscript. The consent form is held by the authors, and is available for
study start February 1, 2014 and through June 2016, 67 review by the Editor-in-Chief.
Kristoffersen et al. Trials (2016) 17:593 Page 8 of 9

Ethics approval and consent to participate 18. Nuss T, Kelly KM, Campbell KR, Pierce C, Entzminger JK, Blair BK, et al.
This study has been performed in accordance with the Declaration of Helsinki The impact of opening visitation access on patient and family experience.
and has been approved by the Regional Committee of Ethics in Medical J Nurs Adm. 2014;44(7/8):403–10.
Research (Mid-Norway) (2013/638/REK midt). 19. Nyqvist KH, Anderson GC, Bergman N, Cattaneo A, Charpak N, Davanzo R, et
al. Towards universal Kangaroo Mother Care: recommendations and report
Author details from the First European conference and Seventh International Workshop on
1
Department of Pediatrics, St. Olav’s University Hospital, Trondheim, Norway. Kangaroo Mother Care. Acta Paediatr. 2010;99(6):820–6.
2
Department of Laboratory Medicine, Children’s and Women’s Health, 20. Harrison H. The principles for family-centered neonatal care. Pediatrics.
Norwegian University of Science and Technology, NTNU, Trondheim, 1993;92(5):643–50.
Norway. 3Department of Clinical Services, St. Olav’s University Hospital, 21. Als H. Toward a synactive theory of development: promise for the assessment
Trondheim, Norway. 4Department of Public Health and General Practice, of infant individuality. Infant Ment Health J. 1982;3:229–43.
NTNU, Trondheim, Norway. 5Department of Circulation and Medical Imaging, 22. Als H. A synactive model of neonatal behavioral organization: framework for
Norwegian University of Science and Technology, NTNU, Trondheim, the assessment of neurobehavioral development in the premature infant
Norway. 6Department of Anesthesia and Intensive Care Medicine, St. Olav’s and for support of infants and parents in the neonatal intensive care
University Hospital, Trondheim, Norway. environment. Phys Occup Ther Pediatr. 1986;6(3–4):3–53.
23. Nordhov SM, Ronning JA, Dahl LB, Ulvund SE, Tunby J, Kaaresen PI. Early
Received: 8 July 2016 Accepted: 24 November 2016 intervention improves cognitive outcomes for preterm infants: randomized
controlled trial. Pediatrics. 2010;126(5):e1088–94.
24. Nordhov SM, Ronning JA, Ulvund SE, Dahl LB, Kaaresen PI. Early intervention
improves behavioral outcomes for preterm infants: randomized controlled
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