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Early Breast Feeding and Glucose Levels in High Risk Newborns

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ClinicalTrials.gov Identifier: NCT00332449
Recruitment Status : Unknown
Verified April 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 1, 2006
Last Update Posted : April 15, 2008
Information provided by:
Sheba Medical Center

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.

Condition or disease
Neonatal Hypoglycemia

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns
Study Start Date : June 2007
Estimated Primary Completion Date : June 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. normal neonatal glucose levels [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Hypoglycemia prevention [ Time Frame: 2 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary clinic clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332449

Contact: Ayala Maayan, MD 972-3-530-2043 ayala.maayan@sheba.health.gov.il

Sheba Medical Center - Neonatal Department Recruiting
Ramat Gan, Tel-Hashomer, Israel, 52621
Contact: Ayala Maayan, MD    972-3-530-2451    ayala.maayan@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Ayala Maayan-Metzger, MD Sheba Medical Center

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00332449     History of Changes
Other Study ID Numbers: SHEBA-06-4112-AM-CTIL
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by Sheba Medical Center:
early breast feeding

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases