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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00332449
Other study ID # SHEBA-06-4112-AM-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received May 31, 2006
Last updated April 14, 2008
Start date June 2007
Est. completion date December 2008

Study information

Verified date April 2008
Source Sheba Medical Center
Contact Ayala Maayan, MD
Phone 972-3-530-2043
Email ayala.maayan@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Day
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Sheba Medical Center - Neonatal Department Ramat Gan Tel-Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary normal neonatal glucose levels 2 days No
Secondary Hypoglycemia prevention 2 days No
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