The effect of an isocaloric, protein- and mineral-enriched ('postdischarge') formula on growth, body composition and bone mineralization of late preterm infants.;Follow-up: The effect of an isocaloric, protein- and mineral-enriched (postdischarge) formula on growth, body composition and neurocognitive development of late preterm infants at the corrected age of 2 years.

The effect of an isocaloric, protein- and mineral-enriched ('postdischarge') formula on growth, body composition and bone mineralization of late preterm infants.;Follow-up: The effect of an isocaloric, protein- and mineral-enriched (*postdischarge*) formula on growth, body composition and neurocognitive development of late preterm infants at the corrected age of 2 years. - LEGO ;Follow-up: LEGO 2.0

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55631

Enrollment

300

Registered

2014-11-27

Start date

2015-06-17

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

(inhaal) groei, hypertensie, cognitieve/motorische/taal-ontwikkeling (catch up) growth metabolic syndrome

Interventions

All infants will be fed human milk and/or protein and mineral enriched formula from birth to term age. At term age, formula fed infants are randomized to PDF or TF and are fed this diet until six mo

Eligibility

Inclusion criteria

Inclusion criteria: Birth at gestational age between 32 0/7 and 35 6/7 weeks., Follow-up: participants of the LEGO-study

Exclusion criteria

Exclusion criteria: - gastro-intestinal surgery and disease known to influence growth (i.e. cystic fibrosis and severe gastro-oesophageal reflux) - known presence of growth hormone, IGF-1 or other pituitary hormone deficiencies - concurrent therapies with substances known or suspected to be associated with alteration of growth (i.e. oral steroids) - cardiac, renal, pulmonary and liver disease - chromosomal and/or genetic syndromes - known skeletal disease - severe illness in general

Design outcomes

Primary

Measure	Time frame
Primary objective: to compare growth and body composition between late preterm infants at 6 months corrected age, fed either isocaloric, protein- en mineral-enriched postdischarge formula or standard term formula between term age and 6 months corrected age. - growth; weight, length and headcircumference - body composition; fat mass and fat free mass Follow-up: - growth: Weight, length, head circumference, waist circumference, - body composition: fat mass and fat free mass	—

Measure

Time frame

Primary objective: to compare growth and body composition between late preterm infants at 6 months corrected age, fed either isocaloric, protein- en mineral-enriched postdischarge formula or standard term formula between term age and 6 months corrected age. - growth; weight, length and headcircumference - body composition; fat mass and fat free mass Follow-up: - growth: Weight, length, head circumference, waist circumference, - body composition: fat mass and fat free mass

—

Secondary

Measure	Time frame
Secondary objective(s): to compare cardio-metabolic risk factors, bone mineral content (and associated serum bone markers) and endocrine parameters between late preterm infants at 6 months corrected age, fed either isocaloric, protein- en mineral-enriched ('postdischarge') formula or standard term formula between term age and 6 months corrected age. Furthermore we will compare all of these parameters between infants fed formula and infants fed (enriched) human milk. - cardio-metabolic risk factors; insulin, glucose, triglycerides, cholesterol - bone mineralization; bone mineral density / bone mineral content - endocrine paramaters; IGF-1, IGF-II, FGF-23 Follow-up: - Neurodevelopment (Bayley-III) - cardio-metabolic risk factors; insulin, glucose, triglycerides, cholesterol - bone mineralization; calcium, phospate, alkaline phosphatase - endocrine paramaters; IGF-1, IGF-II, FGF-23 - other parameters: Hb, ferritin	—

Measure

Time frame

Secondary objective(s): to compare cardio-metabolic risk factors, bone mineral content (and associated serum bone markers) and endocrine parameters between late preterm infants at 6 months corrected age, fed either isocaloric, protein- en mineral-enriched ('postdischarge') formula or standard term formula between term age and 6 months corrected age. Furthermore we will compare all of these parameters between infants fed formula and infants fed (enriched) human milk. - cardio-metabolic risk factors; insulin, glucose, triglycerides, cholesterol - bone mineralization; bone mineral density / bone mineral content - endocrine paramaters; IGF-1, IGF-II, FGF-23 Follow-up: - Neurodevelopment (Bayley-III) - cardio-metabolic risk factors; insulin, glucose, triglycerides, cholesterol - bone mineralization; calcium, phospate, alkaline phosphatase - endocrine paramaters; IGF-1, IGF-II, FGF-23 - other parameters: Hb, ferritin

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)