Provider Approaches to Improved Rates of Infant Nutrition and Growth Study - Full Text View

Sponsors and Collaborators:	Albert Einstein College of Medicine of Yeshiva University National Institutes of Health (NIH)
Information provided by:	Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:	NCT00643253

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

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

Condition	Intervention	Phase
Breastfeeding	Behavioral: LC and Electronic Prompt	Phase III

MedlinePlus related topics: Ataxia Telangiectasia Breast Feeding Children's Health Infant and Toddler Nutrition Prenatal Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Provider Approaches to Improved Rates of Infant Nutrition and Growth Study

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:

Breastfeeding intensity at 1,3, and 6 months [ Time Frame: 1,3, and 6 months after birth of the baby ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Infant growth by treatment group and breastfeeding intensity [ Time Frame: Assessed when baby is 1,3, and 6 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment:	275
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

1: Experimental

Receipt of behavioral interventions to encourage breastfeeding.

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.

2: No Intervention

Standard of Care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643253

Contacts

Contact: Karen A. Bonuck, PhD	718 430 4085	kbonuck@montefiore.org
Contact: Jennifer Lischewski, MPH		jlischew@aecom.yu.edu

Locations

United States, New York
Dept of Obstetrics, Gynecology, and Women's Health/Centennial Building/Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Karen Bonuck kbonuck@montefiore.org
Principal Investigator: Karen Bonuck, PhD

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Karen A. Bonuck, PhD

Albert Einstein College of Medicine of Yeshiva University

More Information

No publications provided

Responsible Party:	Albert Einstein College of Medicine ( Dr. Karen Bonuck )
Study ID Numbers:	2007-490-000, 1P60MD00516
Study First Received:	March 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00643253 History of Changes
Health Authority:	United States: National Institutes of Health; United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:

exclusive breastfeeding
breastfeeding promotion
health promotion

ClinicalTrials.gov processed this record on May 07, 2009