Insulin sensitivity in preterm appropriate-for-gestational-age and small-for-gestational-age infants

Not Applicable

Completed

• Conditions: Small for gestational age, prematurity, insulin sensitivity; Pregnancy and Childbirth; Prematurity

• Registration Number: ISRCTN45943101
• Lead Sponsor: Diabetes Fonds Nederland (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Study Completion: 2008-04-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1. Premature infants 28 to 32 weeks gestational age
2. Presence of a (central) venous and arterial catheter for clinical reasons
3. For preterm SGA infants: growth retardation caused by placental insufficiency, assessed by maternal history (pregnancy induced hypertension, preeclampsia), and confirmed by Doppler flow measurements of the umbilical arteries (Pulsatility Index [PI] more than +2 Standard Deviation [SD] for gestational age, measured on two occasions)

Exclusion Criteria

1. For preterm SGA infants: growth retardation based on other causes (e.g. congenital infections, congenital malformations)
2. Major congenital malformations
3. Severe perinatal asphyxia defined as five minute Apgar score less than seven
4. Severe disturbances of glucose metabolism (glucose intake less than 4 or more than 8 mg.kg-1.min-1, or need for insulin therapy to maintain the glucose concentration between 2.6 and 8 mmol/l)
5. Severe respiratory distress. Mild ventilatory support is allowed:
a. nasal Continuous Positive Airway Pressure (nCPAP) with maximum Fraction of Inspired Oxygen (FiO2) of 0.40, maximum Positive End Expiratory Pressure (PEEP) 6 cm Water (H2O)
b. Synchronised Intermittent Mandatory Ventilation (SIMV) with maximum inspiratory peak pressure of 18 cm H2O and maximum FiO2 of 0.40
c. High Frequency Oscillatory Ventilation (HFOV) with maximum continuous distending pressure of 12 cm H2O and maximum FiO2 of 0.30
6. Need of vasopressor support for hypotension
7. Treatment with systemic corticosteroids
8. Clinical or laboratory evidence of sepsis: lethargy or irritability, hypo- or hyperthermia, temperature instability, tachypnea, apnea, bradycardia, hypotension, gastric retention, abdominal distension, pallor, elevated C- Reactive Protein (CRP)-level, leukocytosis or leukocytopenia and increased number of band neutrophils
9. Low haemoglobin level at the study days with need for a blood transfusion
10. Positive family history for type two diabetes in first degree relatives
11. No informed consent from parents or legal guardians

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of appearance and disappearance of glucose during insulin infusion

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of gluconeogenesis and glycogenolysis<br> 2. Plasma Free Fatty Acid (FFA) concentrations<br> 3. Plasma concentrations of insulin, cortisol and adiponectin<br>