Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breastfeeding
- Sponsor
- Albert Einstein College of Medicine
- Enrollment
- 299
- Locations
- 1
- Primary Endpoint
- Breastfeeding intensity at 1,3, and 6 months
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.
The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.
Primary Outcomes (Hypotheses): Breastfeeding
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Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
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Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.
Secondary Outcomes (Hypotheses): Infant Growth
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Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits.
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Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.
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Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits
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Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.
Investigators
Karen Bonuck
Professor
Albert Einstein College of Medicine
Eligibility Criteria
Inclusion Criteria
- •12-30 weeks pregnant
- •receives prenatal care at Centennial women's center of Montefiore Medical Center
- •English or Spanish speaking
Exclusion Criteria
- •pregnant with multiples
- •breastfeeding contra-indicated
Outcomes
Primary Outcomes
Breastfeeding intensity at 1,3, and 6 months
Time Frame: 1,3, and 6 months after birth of the baby
Secondary Outcomes
- Infant growth by treatment group and breastfeeding intensity(Assessed when baby is 1,3, and 6 months of age)