Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Breastfeeding Clinical Trial

— PAIRINGS  

Official title:

Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643253
• Other study ID #: 2007-490-000
• Secondary ID: 1P60MD00516
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2008
• Last updated: July 9, 2013
• Start date: March 2008
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Albert Einstein College of Medicine of Yeshiva University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institutes of HealthUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: July 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
United States	Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine of Yeshiva University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding intensity at 1,3, and 6 months		1,3, and 6 months after birth of the baby	No
Secondary	Infant growth by treatment group and breastfeeding intensity		Assessed when baby is 1,3, and 6 months of age	No