Family Nurture Intervention in the CHoNJ NICU

NCT02352142 | Terminated

• 1 other identifier: AAAN6850
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. These include early and repeated mother/infant calming interactions during the NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory exposure and family practice in comforting, and systematically implemented skin to skin holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI have significant increases in EEG power, a measure of brain activity, near to term age, when compared with those who receive Standard Care. There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot subjects will be enrolled to train the staff involved in the procedures used in this Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study patients and will be encouraged to participate fully. They will not be included in the analysis of the RCT. The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION group, in addition to the standard care, will receive the FNI intervention, which will be facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a third non-randomized group of infants born at term age who will receive standard care for newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG), measures of maternal sensitivity through recorded mother-infant interactions and a variety of specimen collections (saliva, blood, and breast milk samples). The investigators will be conducting two follow up studies, at 4 months corrected age and at 12 months corrected age. The investigators will test the immediate and long-term effects of this approach to the development of preterm infants. The investigators hypothesize that this intervention will alter a wide range of indices of physiological regulatory capacities, and increase brain activity as measured by EEG (power and coherence) such that a brain activation pattern in the intervention group will be more similar to that of full term infants as opposed to the standard care group. Longer term indices of mother psychological and infant neurobehavioral outcomes will also be improved when assessed during the first few months of life.

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)

• EEG measures of power and coherence

  Two one-hour sleep EEGs will take place. One at 34-36 weeks Gestational Age, and one at term age

  34 weeks gestational age through term age

Secondary Outcomes (9)

• Maternal measures of anxiety, depression and care-giving

  Up to 12 months of age

• Measure of mother time spent with infant in unit and in skin to skin

  Duration of infant stay in unit (roughly 35 days)

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

  Up to 12 month corrected age

• Physiological Assessments- salivary cortisol

  Up to 24 months corrected age

• Physiological Assessments- breast milk

  The duration of the infant stay in unit, or an average of 5 weeks

Study Arms (3)

Standard Care

NO INTERVENTION

Mothers are given infant care instruction as part of standard care

Facilitated infant care

EXPERIMENTAL

Family Nurture Intervention

Behavioral: Facilitated Infant Care

Full Term EEG

OTHER

Small group of healthy, Full-Term infants will receive two sleep EEGs (one in unit, and one 4 weeks post discharge) for healthy control comparison to preterm infants

Other: Full Term EEG

Interventions

Full Term EEG OTHER

Full-term infants assigned to this arm of the study will receive one sleep EEG (one hour in duration). These EEGs will be used as healthy control comparisons to those of premature infants at 40 weeks.

Full Term EEG

Facilitated Infant Care 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.

Also known as: Family Nurture Intervention

Facilitated infant care

Eligibility Criteria

• Age: 26 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant is between 26/0 and 32/6 weeks gestational age upon admission for the INTERVENTION / STANDARD care group OR 38-42 weeks for the FULL TERM group
• Infant's weight is appropriate for gestational age (AGA)
• Infant is a singleton
• Mother is 18 years of age or older
• Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent) (not applicable for FULL TERM group)

You may not qualify if:

• Infant's attending does not recommend enrollment in study
• The infant has severe congenital anomalies, including chromosomal anomalies or an Intraventricular Hemorrhage (IVH) Grades 3 and 4
• Mother has known history of substance abuse, severe psychiatric illness or psychosis
• Mother and/or infant has a medical condition that precludes intervention components
• Mother and/or infant has a contagion that endangers other participants in the study
• Mother-Infant dyad receives less than one week of intervention (not applicable to the FULL TERM group)

Sponsors & Collaborators

• Columbia University: lead
• Newark Beth Israel Medical Center: collaborator

Study Sites (2)

Children's Hospital of New Jersey

Newark, New Jersey, 07112, United States

Location

Columbia University Data Coordinating Center

New York, New York, 10032, United States

Location

Related Publications (9)

• 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

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 Medical Center, Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 26, 2016

Record last verified: 2016-07

Locations

US (2)