Family Nurture Intervention in the CHoNJ NICU

Stopped early · Not applicable

Conditions studied: Premature Birth

In brief

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.

Key facts

Study ID

NCT02352142

Run by

Columbia University

People needed

54

Starts

2015-01-01

Expected to finish

2016-05-01

Last updated by the study team

2016-09-26

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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
• Status of enrolled subject changes and subject no longer falls in inclusion criteria
• 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)

Where it is running

• Children's Hospital of New Jersey — Newark, New Jersey, United States
• Columbia University Data Coordinating Center — New York, New York, United States

Full record on ClinicalTrials.gov

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