Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bronx, New York 10467


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

2007-490-000


NCT ID:

NCT00643253


Secondary ID:

1P60MD00516


Study Acronym:

PAIRINGS


Brief Title:

Provider Approaches to Improved Rates of Infant Nutrition and Growth Study


Official Title:

Provider Approaches to Improved Rates of Infant Nutrition and Growth Study


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Albert Einstein College of Medicine of Yeshiva University


Oversight Authority:

  • United States: National Institutes of Health
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

299


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:March 2008
Completion Date:July 2013
Completion Type:Actual
Primary Completion Date:September 2012
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 9, 2013
First Received Date:March 24, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Infant growth by treatment group and breastfeeding intensity
Time Frame:Assessed when baby is 1,3, and 6 months of age
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Breastfeeding intensity at 1,3, and 6 months
Time Frame:1,3, and 6 months after birth of the baby
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:LC and Electronic Prompt
Description: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 breastfeedin
Arm Name:1
Other Name:breastfeeding promotion

Study Arms

Study Arm Type:No Intervention
Arm Name:2
Description:Standard of Care
Study Arm Type:Experimental
Arm Name:1
Description:Receipt of behavioral interventions to encourage breastfeeding.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Albert Einstein College of Medicine of Yeshiva University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.