Early Breast Feeding and Glucose Levels in High Risk Newborns
Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns
1 other identifier
observational
100
1 country
1
Brief Summary
Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2007
1 active site
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
May 31, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedApril 15, 2008
April 1, 2008
1 year
May 31, 2006
April 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
normal neonatal glucose levels
2 days
Secondary Outcomes (1)
Hypoglycemia prevention
2 days
Eligibility Criteria
primary clinic clinic
You may qualify if:
- Newborns to diabetic mothers
- Newborns to hypertensive mothers
- Newborns with birth weight greater than 4 Kg or less than 2.5 Kg
- Newborns with meconium stained amniotic fluid
You may not qualify if:
- Newborns with major congenital malformation
- Preterm babies
- Newborns with post-birth distress
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center - Neonatal Department
Ramat Gan, Tel-Hashomer, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayala Maayan-Metzger, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 31, 2006
First Posted
June 1, 2006
Study Start
June 1, 2007
Primary Completion
June 1, 2008
Study Completion
December 1, 2008
Last Updated
April 15, 2008
Record last verified: 2008-04