Provider Approaches to Improved Rates of Infant Nutrition and Growth Study (PAIRINGS)
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|ClinicalTrials.gov Identifier: NCT00643253|
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : July 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: LC and Electronic Prompt||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Provider Approaches to Improved Rates of Infant Nutrition and Growth Study|
|Study Start Date :||March 2008|
|Primary Completion Date :||September 2012|
|Study Completion Date :||July 2013|
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
- Breastfeeding intensity at 1,3, and 6 months [ Time Frame: 1,3, and 6 months after birth of the baby ]
- Infant growth by treatment group and breastfeeding intensity [ Time Frame: Assessed when baby is 1,3, and 6 months of age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.|