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Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial.

ABSTRACT: 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.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.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.ClinicalTrials, NCT02024854 . Registered on 19 December 2013.

SUBMITTER: Kristoffersen L

PROVIDER: S-EPMC5153813 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial.

Kristoffersen Laila L Støen Ragnhild R Rygh Hilde H Sognnæs Margunn M Follestad Turid T Mohn Hilde S HS Nissen Ingrid I Bergseng Håkon H

Trials 20161212 1

<h4>Background</h4>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 ear ...[more]

PMID: 27955652

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Project description:BackgroundSkin-to-skin contact (SSC) is an evidence-based intervention that benefits low birth weight /preterm infants. However, China's health institutional policy inhibits parents from visiting their baby in the neonatal intensive care unit (NICU). In addition, the Chinese traditional postpartum behavioral practice of confining women to home raises barriers to mother-infant contact. Thus, to shorten the duration of parent-infant separation, father-infant SSC is considered a possible alternative. This study determines whether it is safe to perform father-infant SSC in the NICU and investigates how paternal SSC affects outcomes compared with traditional care (TC) for moderately preterm infants.Methods/designA randomized controlled trial will be used to investigate the effects of paternal-infant SSC in NICU wards in China. Preterm infants born at a gestational age in the range of 320-346 weeks with a birth weight > 1500 g will be eligible. A simple random sampling method will be used to allocate infants to the SSC group (n = 25) or the TC group (n = 25). After medical stability, infants in the SSC group will be provided SSC by fathers for one hour every day until discharged from hospital. The primary outcome is neurodevelopmental measures, specifically salivary cortisol and Premature Infant Pain Profile (PIPP) during hospitalization. At 40 weeks of corrected age, infants will be assessed using the Infant Neurological International Battery (INFANIB) and neuroimaging. Secondary outcomes include infants' physiological stability during SSC and throughout hospitalization and state observation at discharge. The fathers' mental health will be assessed with the State-Trait Anxiety Inventory (STAI) 1 day to 3 days after the infant's admission to the NICU and at discharge. Father-infant attachment will be evaluated at 4 and 6 months after the infants' discharge, measured by the Paternal Postnatal Attachment Scale (PPAS). Statistical analyses will be conducted using a two-sided significance level of 0.05.DiscussionThe effects of paternal-infant SSC on moderately preterm infants will be assessed. The data gathered in this study may have important implications for medical practice and policy in the NICU regarding the care methods of premature infants in China.Trial registrationChinese Clinical Trial Registry, ChiCTR-IOR-1701274 . Registered on 20 September 2017. Retrospectively registered.

Project description:BackgroundNecrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants.MethodsThe study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age.ResultsA total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).ConclusionRepeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.

Project description:BackgroundSkin-to-skin contact (SSC) is an important factor to consider in the care of late preterm infants (born between 34 0/7 and 36 6/7 completed weeks of gestation). The literature suggests that SSC between preterm infants and their mothers facilitates breastfeeding. However, more studies are needed to explore potential dose-response effects between SSC and breastfeeding as well as studies that explicitly investigate SSC by fathers among late preterm infants. The aim was to investigate the duration of healthy late preterm infants' SSC with the mother and father, respectively, during the first 48 h after birth and the associations with breastfeeding (exclusive/partial at discharged), clinical and demographic variables.MethodsThis was an observational cohort study in which parents to healthy late preterm infants, born between 34 5/7 and 36 6/7 completed weeks of gestation, recorded duration of SSC provided by mother and father, respectively. Demographic and clinical variables were retrieved from the medical records and were used as predictors. Multiple linear regression analysis was used to assess the association between the predictors and the outcome, SSC (hours), separately for mothers and fathers.ResultsThe mean (standard deviation [SD]) time per day spent with SSC with mothers (n = 64) and fathers (n = 64), was 14.7 (5.6) and 4.4 (3.3) hours during the first day (24 h) after birth and 9.2 (7.1) and 3.1 (3.3) hours during the second day (24 h), respectively. Regarding SSC with mothers, no variable was significantly associated with SSC during the first day, while the mean (95% confidence interval [CI]) time of SSC during the second day was 6.9 (1.4-12.4) hours shorter for each additional kg of birthweight (p = 0.014). Concerning SSC with fathers, the mean (95% CI) time of SSC during the first day was 2.1 (0.4-3.7) hours longer for infants born at night (p = 0.015), 1.7 (0.1-3.2) hours longer for boys (p = 0.033), 3.2 (1.2-5.2) hours longer for infants born by caesarean section (p = 0.003), and 1.6 (0.1-3.1) hours longer for infants exclusively breastfed at discharge (p = 0.040). During the second day, the mean (95% CI) time of SSC with fathers was 3.0 (0.6-5.4) hours shorter for each additional kg of birthweight (p = 0.014), 2.0 (0.5-3.6) hours longer for infants born during night-time (p = 0.011), 2.9 (1.4-4.4) hours longer if the mother was primipara (p < 0.001), and 1.9 (0.3-3.5) hours shorter if supplementary artificial milk feeds were given. None of the other predictors, i.e., mother's age, gestational age, or induction of labor were significantly associated with infants' SSC with mothers or fathers during any of the first two days after birth.ConclusionFuture studies are warranted that investigate duration of SSC between late preterm infants and their parents separately and the associations with breastfeeding and other variables of clinical importance.

Project description:IntroductionIn Scandinavia, 6% of infants are born preterm, before 37 gestational weeks. Instead of continuing in the in-utero environment, maturation needs to occur in a neonatal unit with support of vital functions, separated from the mother's warmth, nutrition and other benefits. Preterm infants face health and neurodevelopment challenges that may also affect the family and society at large. There is evidence of benefit from immediate and continued skin-to-skin contact (SSC) for term and moderately preterm infants and their parents but there is a knowledge gap on its effect on unstable very preterm infants when initiated immediately after birth.Methods and analysisIn this ongoing randomised controlled trial from Stavanger, Norway and Stockholm, Sweden, we are studying 150 infants born at 28+0 to 32+6 gestational weeks, randomised to receive care immediately after birth in SSC with a parent or conventionally in an incubator. The primary outcome is cardiorespiratory stability according to the stability of the cardiorespiratory system in the preterm score. Secondary outcomes are autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health.Ethics and disseminationThe study has ethical approval from the Swedish Ethical Review Authority (2017/1135-31/3, 2019-03361) and the Norwegian Regional Ethical Committee (2015/889). The study is conducted according to good clinical practice and the Helsinki declaration. The results of the study will increase the knowledge about the mechanisms behind the effects of SSC for very preterm infants by dissemination to the scientific community through articles and at conferences, and to the society through parenting classes and magazines.Study statusRecruiting since April 2018. Expected trial termination June 2021.Trial registration numberNCT03521310 (ClinicalTrials.gov).

Project description:BackgroundPreterm infants are high risk for delayed neurodevelopment. The main goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home, and quantify the results of early parental stimulation on improvement of cognition and motor skills.MethodsRandomized clinical Trial including inborn preterm infants with gestational age less than 32 weeks or birth weight less than 1500 g at 48 h after birth. Eligible for begin the intervention up to 7 days after birth. Study Protocol approved by the Brazilian national Committee of ethics in Research and by the institutional ethics committee. Intervention group (IG): skin-to skin care by mother (kangaroo care) plus tactile-kinesthetic stimulation by mothers from randomization until hospital discharge when they receive a program of early intervention with 10 parents' orientation and a total of 10 home visits independently of the standard evaluation and care that will be performed. Systematic early intervention program will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. Active comparator with a Conventional Group (CG): standard care according to the routine care of the NICU and their needs in the follow up program. Neurodevelopment outcome with blinded evaluations in both groups between 12 and 18 months by Bayley Scales of Infant and Toddler Development third edition and Alberta Motor Infant scale will be performed. All evaluations will be conducted in the presence of parents or caregivers in a safe room for the child move around during the evaluation.DiscussionIf we can show that a continuous and global early intervention at home performed by low income families is better than the standard care for very preterm infants, this kind of program may be applied elsewhere in the world. We received grants by Bill and Melinda Gates Foundation, DECIT, Cnpq and Health Ministry. Grand Challenges Brazil: All Children Thriving.Trial registrationThe study was restrospectively registered in ClinicalTrials.gov . in July 15 2016 ( NCT02835612 ).

Project description:BackgroundNeurobehavioral disabilities occur in 5-15% of preterm infants with an estimated 50-70% of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants' neurobehavioral organization and development, cognitive function, and clinical outcomes.MethodsThis trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors (perinatal events and conditions of maternal or fetal/newborn origin and immunologic and genetic biomarkers) on the outcome variables will also be considered.DiscussionTheoretically, the intervention provided at a critical time in neurologic system development and associated with a recurring event (feeding) should enhance neural connections that may be important for later development, particularly language and other cognitive and neurobehavioral organization skills.Trial registrationNCT01577615 11 April 2012.

Project description:This randomized controlled trial evaluated the effect of a 5-week daily skin-to-skin contact (SSC) intervention between mothers and their full-term infants, compared with care-as-usual, on exclusive and continued breastfeeding duration during the first post-natal year. Healthy pregnant women (n = 116) from a community sample were enrolled and randomly allocated to the SSC or care-as-usual condition. SSC mothers were requested to provide one daily hour of SSC for the first five post-natal weeks. Twelve months post-partum, mothers indicated the number of exclusive and continued breastfeeding months. Multiple regression analyses were conducted using intention-to-treat, per-protocol and exploratory dose-response frameworks. In intention-to-treat analyses, exclusive and continued breastfeeding duration was not different between groups (exclusive: 3.61 ± 1.99 vs. 3.16 ± 1.77 months; adjusted mean difference 0.28, 95% confidence interval [CI] -0.33 to 0.89; p = 0.36; continued: 7.98 ± 4.20 vs. 6.75 ± 4.06 months; adjusted mean difference 0.81, 95% CI -0.46 to 2.08; p = 0.21). In per-protocol analyses, exclusive and continued breastfeeding duration was longer for SSC than care-as-usual dyads (exclusive: 4.89 ± 1.26 vs. 3.25 ± 1.80 months; adjusted mean difference 1.28, 95% CI 0.31-2.24; p = 0.01; continued: 10.81 ± 1.97 vs. 6.98 ± 4.08 months; adjusted mean difference 2.33, 95% CI 0.13-4.54; p = 0.04). Exploratory dose-response effects indicated that more SSC hours predicted longer exclusive and continued breastfeeding duration. This study demonstrates that for the total group, the 5-week daily SSC intervention did not extend exclusive and continued breastfeeding duration. However, for mothers performing a regular daily hour of SSC, this simple and accessible intervention may extend exclusive and continued breastfeeding duration by months. Future studies are required to confirm these promising findings. Trial registration: Netherlands Trial Register (NTR5697).

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Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial.

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Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial.

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