We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Breast Feeding and Glucose Levels in High Risk Newborns

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332449
First Posted: June 1, 2006
Last Update Posted: April 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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:


Further study details as provided by Sheba Medical Center:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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


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   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ayala Maayan-Metzger, MD Sheba Medical Center
  More Information

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 Submitted: May 31, 2006
First Posted: June 1, 2006
Last Update Posted: April 15, 2008
Last Verified: April 2008

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

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases