Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Official Title: “Provider Approaches to Improved Rates of Infant Nutrition and Growth Study”

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

1. 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.

2. 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

3. 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.

4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.

5. 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

6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Receipt of behavioral interventions to encourage breastfeeding.
• No Intervention: 2
  • Standard of Care

Primary Measures

• Breastfeeding intensity at 1,3, and 6 months
  • Time Frame: 1,3, and 6 months after birth of the baby
    Safety Issue?: No

Secondary Measures

• Infant growth by treatment group and breastfeeding intensity
  • Time Frame: Assessed when baby is 1,3, and 6 months of age
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Albert Einstein College of Medicine of Yeshiva University Other

Overall Clinical Trial Officials and Contacts

Karen A. Bonuck, PhD Principal Investigator Albert Einstein College of Medicine of Yeshiva University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643253

Study ID Number: 2007-490-000

ClinicalTrials.gov Identifier: NCT00643253

Health Authority: United States: National Institutes of Health