Trial reportPloS one2020
Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial.
Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01439269 (Enhancement of Co-regulation Between Mother and Infant Via Family Nurture Intervention), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Enhancement of Co-regulation Between Mother and Infant Via Family Nurture Intervention (FNI) in the NICU: Short and Long Term Effects on Development
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.
- A systematic review and meta-analysis of the association between parenting and child autonomic nervous system activity.Neuroscience and biobehavioral reviews · 2022Pooled it
- Maternal singing sustains preterm hospitalized newborns' autonomic nervous system maturation: an RCT.Pediatric research · 2024Trial
- Effects of an attachment-based intervention on autonomic regulation among opioid-exposed infants.Developmental psychobiology · 2022Trial
- The preterm infant-parent programme for attachment-PIPPA Study: a randomised controlled trial.Pediatric research · 2021Trial
- Regulation of Stress Physiology Across Social Contexts in Preterm-Born Preschoolers.Psychophysiology · 2026Article
- Parents' Speech in the NICU and Language Development of Very Preterm Children at 12 and 24 Months.Journal of pediatrics. Clinical practice · 2025Article
- Maternal singing and speech have beneficial effects on preterm infant's general movements at term equivalent age and at 3 months: an RCT.Frontiers in psychology · 2025Article
- Exposure to the parents' speech is positively associated with preterm infant's face preference.Pediatric research · 2024Article
- Optimal presence: enhancing parent integration to maximize neurodevelopmental outcomes in preterm infants.Pediatric research · 2024Review
- Fantastic voyage:Comprehensive psychoneuroendocrinology · 2024Review
- Enhancing early bonding between mothers and preterm infants: findings from a Multicentre Qualitative Study of Nurses.Revista latino-americana de enfermagem · 2024Article
- Touch medicine: bridging the gap between recent insights from touch research and clinical medicine and its special significance for the treatment of affective disorders.Frontiers in psychiatry · 2024Review
- Preschool mother-child emotional preparation program leads to significant improvement in autonomic regulation: a randomized controlled trial.Frontiers in child and adolescent psychiatry · 2024Article
- Six weeks that changed the preterm infant brain: lessons learned from the Family Nurture Intervention randomized controlled trials.Frontiers in psychology · 2024Review
- Preschool-based mother-child emotional preparation program improves emotional connection, behavior regulation in the home and classroom: a randomized controlled trial.Frontiers in child and adolescent psychiatry · 2023Article
- Environmental contaminants and child development: Developmentally-informed opportunities and recommendations for integrating and informing child environmental health science.New directions for child and adolescent development · 2022Article
- Effects of Family Nurture Intervention in the NICU on Theory of Mind Abilities in Children Born Very Preterm: A Randomized Controlled Trial.Children (Basel, Switzerland) · 2022Article
- Neurobehavioral Phenotype and Dysexecutive Syndrome of Preterm Children: Comorbidity or Trigger? An Update.Children (Basel, Switzerland) · 2022Review
- [Touch Medicine - a complementary therapeutic approach exemplified by the treatment of depression].Deutsche medizinische Wochenschrift (1946) · 2022Article
- Development and reliability of the coding system evaluating maternal sensitivity to social interactions with 34- to 36-week postmenstrual age preterm infants.Frontiers in psychiatry · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMaturation of multiple neurobehavioral systems, including autonomic regulation, is altered by preterm birth. The purpose of this study was to determine the long-term effects of Family Nurture Intervention (FNI) in the NICU on autonomic regulation of preterm infants and their mothers.
methodA subset of infants and mothers (48% of infants, 51% of mothers) randomly assigned to either standard are (SC), or SC plus the FNI in the NICU in a prior RCT (ClincalTrials.gov; NCT01439269) returned for follow-up assessments when the children were 4 to 5 years corrected age (CA). ECGs were collected for 10 minutes in mothers and their children while children were in their mothers' laps. Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency were quantified.
resultsBoth children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031). In addition, RSA increased more rapidly in FNI children between infancy and the 4 to 5-year follow-up time point (SC = +3.11±0.16 loge msec2, +3.67±0.19 loge msec2 for FNI, p<0.05). These results show that the rate of increase in RSA from infancy to childhood is more rapid in FNI subjects.
conclusionAlthough these preliminary follow-up results are based on approximately half of subjects originally enrolled in the RCT, they suggest that FNI-NICU led to healthier autonomic regulation in both mother and child, when measured during a brief face-to-face socioemotional interaction. A Pavlovian autonomic co-conditioning mechanism may underly these findings that can be exploited therapeutically.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.