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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: Completed Phase 3 study, sponsored by Albert Einstein College of Medicine.
NCT00643253 is a Phase 3 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 299 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00643253 record still lists
NCT00643253 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which LC and Electronic Prompt is the first listed.
NCT00643253 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00643253's enrollment target sits among peer trials
299 1161st of 2000 higher than 839 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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