Early Breast Feeding and Glucose Levels in High Risk Newborns

Neonatal Hypoglycemia Clinical Trial

Official title:

Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00332449
• Other study ID #: SHEBA-06-4112-AM-CTIL
• 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

• Hypoglycemia
• Neonatal Hypoglycemia

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