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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 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. The trial reports 2 study locations across 2 states.

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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

FieldValue
Enrollment Target 17,000 participants
Start Date 2002-10
Est. Completion 2006-01
Phase Phase 3

What the Registry Record Tells You About NCT00109616

The ClinicalTrials.gov registry entry for NCT00109616 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 17,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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