Provider Approaches to Improved Rates of Infant Nutrition and Growth Study (PAIRINGS)
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
- 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.
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
- 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.
- Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.
- 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
- Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Provider Approaches to Improved Rates of Infant Nutrition and Growth Study|
- Breastfeeding intensity at 1,3, and 6 months [ Time Frame: 1,3, and 6 months after birth of the baby ] [ Designated as safety issue: No ]
- Infant growth by treatment group and breastfeeding intensity [ Time Frame: Assessed when baby is 1,3, and 6 months of age ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||July 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Receipt of behavioral interventions to encourage breastfeeding.
Behavioral: LC and Electronic Prompt
Women will receive: a) International Board of Certified Lactation Consultant (IBCLC) education/counseling during the pre-natal, intra-partum and post-hospital discharge period to promote early and continued exclusive breastfeeding. The protocol specifies 2 prenatal meetings, a hospital visit, and a home visit if indicated and accepted, and; b) Electronic Medical Record Prompts- will appear on the prenatal record 5 times throughout the pregnancy. They are brief discussion points re breastfeeding that the provider is asked to raise with their patients.
No Intervention: 2
Standard of Care
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643253
|United States, New York|
|Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Karen A. Bonuck, PhD||Albert Einstein College of Medicine of Yeshiva University|