Early Breast Feeding and Glucose Levels in High Risk Newborns

April 14, 2008 updated by: Sheba Medical Center

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- Tel-Hashomer
  - Ramat Gan, Tel-Hashomer, Israel, 52621
    - Recruiting
    - Sheba Medical Center - Neonatal Department
    - Contact:
      
      Ayala Maayan, MD
      
      Phone Number: 972-3-530-2451
      
      Email: ayala.maayan@sheba.health.gov.il

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 day (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary clinic clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
normal neonatal glucose levels Time Frame: 2 days	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Hypoglycemia prevention Time Frame: 2 days	2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

Principal Investigator: Ayala Maayan-Metzger, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria