Glucose in Well Babies Study (GLOW): An observational study to determine the glucose profile in healthy babies within the first five postnatal days.

Not Applicable

Completed

• Conditions: To describe the normal concentrations of blood glucose, lactate and ketones within the first five postnatal days.; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12615000986572
• Lead Sponsor: Waikato District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Babies who are
1. 37 to 42 weeks’ gestation and assessed as appropriate for gestational age at birth.
2. Appropriate weight for gestational age (birth weight > 10th centime and < 90th centile).
3. Singletons
4. Living within 20 kilometers of Waikato Hospital
5. English-speaking parents

Exclusion Criteria

Babies will be excluded who have any of the following
1. Birthweight < 2500g or > 4500 g
2. Apgar score < 7 at five minutes of age
3. Skin conditions preventing the attachment of the continuous glucose monitor
4. Unwell for any reason
5. Major congenital abnormalities or terminal conditions.
6. Born to mothers with an antenatal history of diabetes, hypertension, drug dependency, or using medications, which may affect the newborns blood glucose concentration, e.g. corticosteroids, sodium valproate.
7. Born to mothers with a Body Mass Index < 18.5 or > 30 kg/m2

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the range and variation of blood glucose concentrations.<br>[within the first five postnatal days. ];To determine the range and variation of interstitial glucose concentrations within the first five postnatal days.[Within the first five postnatal days]

Secondary Outcome Measures

Name	Time	Method
To determine the incidence of blood glucose concentrations < 2.6mM within the first 48 hours after birth[Within the first 48 hours after birth];To determine the range and variation of blood lactate concentrations.[Within the first five postnatal days];To determine the range and variation of blood ketone concentrations.[Within the first five postnatal days];To determine the differences, if any, between breast-fed and formula fed babies in blood glucose concentrations.[Within the first five postnatal days];To determine the differences, if any, between breast-fed and formula fed babies in blood lactate concentrations.[within the first five postnatal days];To determine the differences, if any, between breast-fed and formula fed babies in blood ketone concentrations.[Within the first five postnatal days]