NCT00332449

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

May 31, 2006

Last Update Submit

April 14, 2008

Conditions

Keywords

early breast feedinghypoglycemianewborn

Outcome Measures

Primary Outcomes (1)

  • normal neonatal glucose levels

    2 days

Secondary Outcomes (1)

  • Hypoglycemia prevention

    2 days

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

primary clinic clinic

You may qualify if:

  • 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

You may not qualify if:

  • Newborns with major congenital malformation
  • Preterm babies
  • Newborns with post-birth distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center - Neonatal Department

Ramat Gan, Tel-Hashomer, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Breast FeedingHypoglycemia

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ayala Maayan-Metzger, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 1, 2006

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations