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NCT00643253 · ClinicalTrials.gov registry record · Phase 3
Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
A Phase 3 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 299
- Enrollment target
NCT00643253 is a Phase 3 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 299 participants.
The verdict
NCT00643253, a Phase 3 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 299 participants
- Enrollment target
Study 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 w
Interventions
- BEHAVIORAL LC and Electronic Prompt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2008-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00643253
The ClinicalTrials.gov registry entry for NCT00643253 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LC and Electronic Prompt is the first listed.
NCT00643253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00643253 about?
NCT00643253 is a clinical study titled "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, ...
What is the current status of trial NCT00643253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2008-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00643253?
The interventions under investigation include: LC and Electronic Prompt (BEHAVIORAL).
Who is sponsoring clinical trial NCT00643253?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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