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Early Breast Feeding and Glucose Levels in High Risk Newborns

NCT ID: NCT00332449

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neonatal Hypoglycemia

Keywords

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early breast feeding hypoglycemia newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Ayala Maayan-Metzger, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center - Neonatal Department

Ramat Gan, Tel-Hashomer, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ayala Maayan, MD

Role: CONTACT

Phone: 972-3-530-2043

Email: [email protected]

Facility Contacts

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Ayala Maayan, MD

Role: primary

Other Identifiers

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SHEBA-06-4112-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id