Effect of Breast Milk Feeding on Critically Ill Neonates
1 other identifier
observational
50
0 countries
N/A
Brief Summary
Globally, the estimated preterm birth rate is estimated at 10.6% of all live births, or about 14.8 million infants per year. Breastfeeding is associated with a reduction of risk for several acute and chronic diseases in women and their infants, and the benefits are especially important for small, sick and preterm infants. Important benefits of breastmilk provision for premature and fragile infants including a reduction of the risk for late-onset sepsis, necrotizing enterocolitis, and ventilator-associated pneumonia. In 2020, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) released The Baby friendly Hospital Initiative (BFHI) for small, sick and preterm newborns. Based on the evidence put forward in this document,this review outlines the main steps that health care professionals and facilities can take to support breastfeeding in vulnerable groups of infants. The objective of this study is to summarize essential steps for healthcare personnel and health care facilities to improve breastfeeding practices in small, sick and preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedApril 18, 2023
April 1, 2023
10 months
March 17, 2023
April 14, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Number of critically ill neonates who receiving breast milk and affect on their weight gain
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding weight gain.
Baseline
Number of critically ill neonates who receiving breast milk and affect on their reflexes
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding reflexes.
Baseline
Number of critically ill neonates who receiving breast milk and affect on their starting of enteral feeding
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding start of enteral feeding
Baseline
Number of critically ill neonates who receiving breast milk and affect on their durtation to stay on mechanical ventilation
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding the stay on mechanical ventilation.
Baseline
Number of critically ill neonates who receiving breast milk and affect on their duration of hospital stay
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding duration of hospital stay.
Baseline
Eligibility Criteria
50 neonates aged (0-28 days)
You may qualify if:
- Neonates with critical illness as RDS,pneumonias,perinatal asphyxia,enterocolitis,meconium aspiration syndrome,neonatal sepsis diagnosed on the basis of clinical signs and symptoms
You may not qualify if:
- neonates cannot breastfeed due to GIT anomalies as esophageal atresia, duodenal atreaia ,congenital hypertrophic pyloric stenosis , intestinal obstruction , metabolic diseases ,complex cardic anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salah El-Din Amry, Prof
Assiut University
- PRINCIPAL INVESTIGATOR
Amira Mohamed, Assist prof
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2023
First Posted
April 18, 2023
Study Start
June 1, 2023
Primary Completion
April 1, 2024
Study Completion
September 1, 2024
Last Updated
April 18, 2023
Record last verified: 2023-04