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Early Breast Feeding and Glucose Levels in High Risk Newborns
This study is currently recruiting participants.
Study NCT00332449   Information provided by Sheba Medical Center
First Received: May 31, 2006   Last Updated: April 14, 2008   History of Changes

May 31, 2006
April 14, 2008
June 2007
June 2008   (final data collection date for primary outcome measure)
normal neonatal glucose levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00332449 on ClinicalTrials.gov Archive Site
Hypoglycemia prevention [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
 
Early Breast Feeding and Glucose Levels in High Risk Newborns
Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns

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.

Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.

 
Observational
Cohort, Prospective
Neonatal Hypoglycemia
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
December 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Newborns with major congenital malformation
  • Preterm babies
  • Newborns with post-birth distress
Both
up to 1 Day
No
Contact: Ayala Maayan, MD 972-3-530-2043 ayala.maayan@sheba.health.gov.il
Israel
 
NCT00332449
Dr. Ayala Maayan, Sheba Medical Center
SHEBA-06-4112-AM-CTIL, No
Sheba Medical Center
 
Principal Investigator: Ayala Maayan-Metzger, MD Sheba Medical Center
Sheba Medical Center
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP