Early Breast Feeding and Glucose Levels in High Risk Newborns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00332449
First received: May 31, 2006
Last updated: April 14, 2008
Last verified: April 2008

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 ]
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Complete list of historical versions of study NCT00332449 on ClinicalTrials.gov Archive Site
Hypoglycemia prevention [ Time Frame: 2 days ] [ Designated as safety issue: No ]
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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
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

primary clinic clinic

Neonatal Hypoglycemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
SHEBA-06-4112-AM-CTIL
No
Dr. Ayala Maayan, Sheba Medical Center
Sheba Medical Center
Not Provided
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