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Insulin sensitivity in preterm AGA and SGA infants.

Insulin sensitivity in preterm AGA and SGA infants.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28578
Enrollment
16
Registered
2007-02-05
Start date
2007-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin sensitivy, insuline sensitiviteit Prematurity, prematuriteit Small for gestational age, dysmaturiteit

Interventions

Not applicable. Observational study

Sponsors

Drs I.A. Zonnenberg Academisch Medisch Centrum Neonatologie, H3-213 Meibergdreef 9 1105 AZ Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Premature infants 28-32 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, >+2 SD for gestational age, measured on two occasions)

Exclusion criteria

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 5 minute Apgar score 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. nCPAP with maximum FiO2 of 0.40, maximum PEEP 6 cm H2O; b. SIMV with maximum inspiratory peak pressure of 18 cm H2O and maximum FiO2 of 0.40; c. 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 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 2 diabetes in first degree relatives; 11. No informed consent from parents or legal guardians.

Design outcomes

Primary

MeasureTime frame
Rate of appearance and disappearance of glucose during insulin infusion

Secondary

MeasureTime frame
1. Rate of gluconeogenesis and glycogenolysis; 2. Plasma FFA concentrations; 3. Plasma concentrations of insulin, cortisol and adiponectin.

Contacts

Public ContactH.P. Sauerwein

Academic Medical Center (AMC), Department of Endocrinology and Metabolism, F5-170, P.O. Box 22660

h.p.sauerwein@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)