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Three-Part Program for Parents With Premature Infants

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status

Completed

Conditions

Premature Birth

Treatments

Behavioral: Brazelton Neonatal Behavioral Assessment Scale
Behavioral: Psychoeducational video
Behavioral: Infant massage

Study type

Interventional

Funder types

NIH

Identifiers

NCT00056680
1R01HD38982-1A6

Details and patient eligibility

About

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.

Full description

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.

Enrollment

173 patients

Sex

All

Ages

32 to 37 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infants born < 37 weeks gestational age
  • Mothers 18 years of age or older
  • African American

Exclusion criteria

  • Infants with chromosomal abnormalities or other genetic syndromes
  • Mothers with positive postpartum toxicology screens
  • Infants destined for foster care

Note: age limits for infants refer to post-conceptual age (not actual age)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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