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NCT00109616 · ClinicalTrials.gov registry record · Phase 3
Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal
A Phase 3 study of Neonatal Mortality, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 17,000
- Enrollment target
- 2
- Study locations
NCT00109616: Completed Phase 3 study of Neonatal Mortality, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00109616 is a Phase 3 study of Neonatal Mortality that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 17,000 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2105% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00109616, a Phase 3 study of Neonatal Mortality, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 17,000 participants
- Enrollment target
- 2
- Study locations
Study Summary
Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant. The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and water or an antiseptic solution for the first few days of life can reduce umbilical cord infections.
Conditions Studied
Interventions
- BEHAVIORAL Newborn skin cleansing with 0.25% chlorhexidine solution
- BEHAVIORAL Cleansing of umbilical cord with soap and water solution
- BEHAVIORAL Cleansing of umbilical cord with 4% chlorhexidine
Study Locations (2)
Maryland
- Johns Hopkins Bloomberg School of Public Health - Baltimore
Other
- Nepal Nutrition Intervention Project-Sarlahi - Kathmandu and Sarlahi District
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,000 participants |
| Start Date | 2002-10 |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00109616 record still lists
NCT00109616 is an interventional study that assigns participants to a tested intervention. Its 17,000 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2105% higher).
The record links to 1 condition, with Neonatal Mortality appearing as the primary indexed condition, and to 3 interventions - of which Newborn skin cleansing with 0.25% chlorhexidine solution is the first listed.
NCT00109616 reports a single indexed study location in Maryland, Other.
Frequently Asked Questions
What is clinical trial NCT00109616 about?
NCT00109616 is a clinical study titled "Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal". Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant. The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortalit...
What is the current status of trial NCT00109616?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 17,000 participants. The study started on 2002-10. Estimated completion is 2006-01.
What conditions does trial NCT00109616 study?
This clinical trial studies the following conditions: Neonatal Mortality.
What interventions are being tested in trial NCT00109616?
The interventions under investigation include: Newborn skin cleansing with 0.25% chlorhexidine solution (BEHAVIORAL), Cleansing of umbilical cord with soap and water solution (BEHAVIORAL), Cleansing of umbilical cord with 4% chlorhexidine (BEHAVIORAL).
Who is sponsoring clinical trial NCT00109616?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00109616 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00109616's enrollment target sits among peer trials
17,000 12th of 2000 higher than 1,989 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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