Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109616
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2005-04-29
Brief Title:
Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Newborn Antiseptic Washing and Neonatal Mortality-Nepal
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
While significant progress has been made in reducing preschool child mortality in developing countries over the past 20 years much less progress has been made in reducing neonatal mortality and morbidity Neonatal mortality rates are high in Nepal a significant proportion of which are due to sepsis In addition the vast majority of women deliver babies at home without a skilled birth attendant and early neonatal care is routinely used in rural areas Previous hospital-based research in Malawi suggested that newborn cleansing with a dilute chlorhexidine solution could reduce early infant mortality This project evaluates the use of a simple intervention at the community level and the impact on neonatal mortality
Comparisons Two nested community-based randomized trials are being conducted The first compares the neonatal mortality rates between newborn infants randomized to receive a whole body skin cleansing soon after birth with baby wipes impregnated with 025 chlorhexidine compared with newborns cleaned with baby wipes with a placebo solution The second trial compares the rates of umbilical cord infections among children assigned to three groups
education of the mother on clean cord care alone
education of the mother plus routine washing of the cord and stump with soap and water solution for the first 10 days of life -OR-
education of the mother plus routine washing of the cord and stump with a 4 chlorhexidine solution
Enrolled infants are visited on a regular basis during the first month of life to record vital status and grade the cord for signs of infection
Comparisons Two nested community-based randomized trials are being conducted The first compares the neonatal mortality rates between newborn infants randomized to receive a whole body skin cleansing soon after birth with baby wipes impregnated with 025 chlorhexidine compared with newborns cleaned with baby wipes with a placebo solution The second trial compares the rates of umbilical cord infections among children assigned to three groups
education of the mother on clean cord care alone
education of the mother plus routine washing of the cord and stump with soap and water solution for the first 10 days of life -OR-
education of the mother plus routine washing of the cord and stump with a 4 chlorhexidine solution
Enrolled infants are visited on a regular basis during the first month of life to record vital status and grade the cord for signs of infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD044004 | NIH | None | httpsreporternihgovquickSearchR01HD044004 |