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OpenTrials
Completed

NCT Number: NCT00643253

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LC and Electronic Prompt

Behavioral

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.

Other names: breastfeeding promotion, lactation consultant intervention, electronic health promotion

Primary outcomes

  1. Breastfeeding intensity at 1,3, and 6 months

    Time frame: 1,3, and 6 months after birth of the baby

Secondary outcomes

  1. Infant growth by treatment group and breastfeeding intensity

    Time frame: Assessed when baby is 1,3, and 6 months of age

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: PAIRINGS

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Mar 26, 2008
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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