Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)

NCT01439269 | Completed

• 1 other identifier: AAAD0389
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.

Conditions

Premature Birth

Keywords

Separation stress; Family Nurture; Maternal Confidence; Maternal Competence; Calming Cycle; Kangaroo Care; Infant Neurodevelopment; Infant Psychological Development; Post-partum depression; Mother-infant Co-regulation

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Length of stay will be determined based on the infant's number of days as an inpatient at the Children's Hospital of New York (CHONY) NICU.

  From Infant's birth to discharge from NICU

Secondary Outcomes (11)

• Safety and Practicability of Intervention

  up to 5 years

• Psychological Assessments: Mothers in both groups are given a wide-range of psychological questionnaires. These include indices of anxiety, depression, temperament, personality, attachment, stress, and social support.

  Up to 24 months of Age

• Neurobehavioral Assessments of Infants: The use of the NICU Network Neurobehavioral Scale (NNNS) to assess infant's neurodevelopmental status

  Up to 40 weeks Gestational Age

• Neurobehavioral Assessments of Infants: Mothers provide a wide range of information about infant's development through questionnaires

  Up to 24 months corrected age

• Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III

  Up to 24 months corrected age

Study Arms (3)

Phase 1: Standard Care

NO INTERVENTION

Mothers are given infant care instruction as part of standard care

Phase 1: Facilitated infant care

EXPERIMENTAL

Family Nurture Intervention (FNI)

Behavioral: Family Nurture Intervention

Phase 2: Effectiveness

ACTIVE COMPARATOR

All participants receiving FNI

Behavioral: Family Nurture Intervention

Interventions

Family Nurture Intervention BEHAVIORAL

Family Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.

Phase 1: Facilitated infant care; Phase 2: Effectiveness

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant is born a singleton or twin in the Morgan Stanley Children's Hospital in New York City
• Infant is born 26 and 34 weeks post-conceptional age (PCA)

You may not qualify if:

• Mothers cannot understand or speak English
• Mother has history of drug addiction, psychosis or other severe mental illness
• There is not at least one adult other than the mother in the home
• Infant birth weight is below the third percentile for gestational age
• Infant has significant congenital defects

Sponsors & Collaborators

• Columbia University: lead
• Williams College: collaborator
• New York State Psychiatric Institute: collaborator

Study Sites (1)

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Related Publications (14)

• Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.

  PMID: 21371754 BACKGROUND

• Muller-Nix C, Forcada-Guex M, Pierrehumbert B, Jaunin L, Borghini A, Ansermet F. Prematurity, maternal stress and mother-child interactions. Early Hum Dev. 2004 Sep;79(2):145-58. doi: 10.1016/j.earlhumdev.2004.05.002.

  PMID: 15324994 BACKGROUND

• Meijssen D, Wolf MJ, van Bakel H, Koldewijn K, Kok J, van Baar A. Maternal attachment representations after very preterm birth and the effect of early intervention. Infant Behav Dev. 2011 Feb;34(1):72-80. doi: 10.1016/j.infbeh.2010.09.009. Epub 2010 Nov 9.

  PMID: 21067812 BACKGROUND

• Meijssen D, Wolf MJ, Koldewijn K, Houtzager BA, van Wassenaer A, Tronick E, Kok J, van Baar A. The effect of the Infant Behavioral Assessment and Intervention Program on mother-infant interaction after very preterm birth. J Child Psychol Psychiatry. 2010 Nov;51(11):1287-95. doi: 10.1111/j.1469-7610.2010.02237.x.

  PMID: 20345840 BACKGROUND

• Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.

  PMID: 21242223 BACKGROUND

• Coppola G, Cassibba R, Costantini A. What can make the difference? Premature birth and maternal sensitivity at 3 months of age: the role of attachment organization, traumatic reaction and baby's medical risk. Infant Behav Dev. 2007 Dec;30(4):679-84. doi: 10.1016/j.infbeh.2007.03.004. Epub 2007 Apr 20.

  PMID: 17449102 BACKGROUND

• DeBoer RW, Karemaker JM, Strackee J. Comparing spectra of a series of point events particularly for heart rate variability data. IEEE Trans Biomed Eng. 1984 Apr;31(4):384-7. doi: 10.1109/TBME.1984.325351. No abstract available.

  PMID: 6745974 BACKGROUND

• Hofer MA. Early social relationships: a psychobiologist's view. Child Dev. 1987 Jun;58(3):633-47.

  PMID: 3608643 BACKGROUND

• Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.

  PMID: 8078162 BACKGROUND

• Welch MG, Barone JL, Porges SW, Hane AA, Kwon KY, Ludwig RJ, Stark RI, Surman AL, Kolacz J, Myers MM. 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. PLoS One. 2020 Aug 4;15(8):e0236930. doi: 10.1371/journal.pone.0236930. eCollection 2020.

  PMID: 32750063 DERIVED

• Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.

  PMID: 30284883 DERIVED

• Hane AA, Myers MM, Hofer MA, Ludwig RJ, Halperin MS, Austin J, Glickstein SB, Welch MG. Family nurture intervention improves the quality of maternal caregiving in the neonatal intensive care unit: evidence from a randomized controlled trial. J Dev Behav Pediatr. 2015 Apr;36(3):188-96. doi: 10.1097/DBP.0000000000000148.

  PMID: 25757070 DERIVED

• Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.

  PMID: 24063360 DERIVED

• Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14. Erratum In: BMC Pediatr. 2012;12:107.

  PMID: 22314029 DERIVED

MeSH Terms

Conditions

Premature Birth; Depression, Postpartum

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Martha G Welch, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 23, 2011
• Study Start: June 1, 2008
• Primary Completion: July 3, 2012
• Study Completion: January 9, 2018
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (1)