An interventional study of Psychoeducational video and Infant massage in Premature Birth, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 5 sites in United States. Open to participants aged 32 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2007-06-20.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Prevention
This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.
Premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree.
This study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. Outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. The project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention.
Participants in this study were urban African American mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for the study if nominated by the child's mother. Participants were randomly assigned to an intervention group or a control group. Both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender.
The intervention group viewed a videotape about preterm infant abilities. Over the course of the study, the intervention group administered infant massage and completed multiple administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement.
The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 173 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
Note: age limits for infants refer to post-conceptual age (not actual age)
Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment
Time frame: collected at 4, 12, and 24 months of infant age
Maternal self-efficacy, parenting stress, perceptions of infant temperament
Time frame: Collected at 4, 12, and 24 months of infant age
This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)