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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
History of Changes
  Purpose

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
Neonatal Hypoglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • normal neonatal glucose levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycemia prevention [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary clinic clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332449

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

Locations
Israel
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    
Contact: ayala Maayan, MD     972-3-530-2451     ayala.maayan@sheba.health.gov.il    
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ayala Maayan-Metzger, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00332449     History of Changes
Other Study ID Numbers: SHEBA-06-4112-AM-CTIL
Study First Received: May 31, 2006
Last Updated: April 14, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
early breast feeding
hypoglycemia
newborn

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013