Provider Approaches to Improved Rates of Infant Nutrition and Growth Study (PAIRINGS)

Albert Einstein College of Medicine

Status and phase: Completed; Phase 3

Conditions: Breastfeeding

Treatments: Behavioral: LC and Electronic Prompt

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00643253

2007-490-000

1P60MD00516

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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299 participants in 2 patient groups

1

Experimental group

Description:

Receipt of behavioral interventions to encourage breastfeeding.

Treatment:

Behavioral: LC and Electronic Prompt

2

No Intervention group

Description:

Standard of Care