Intake and growth in late preterms

Intake and growth in late preterms - Intake and growth in late preterms

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44660

Enrollment

200

Registered

2015-04-30

Start date

2016-02-08

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

neonatologie, groei, voeding en ontwikkeling nutritional management and preterms

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - born between 32 and 35 6/7 weeks of gestational age - will not be transferred to an other hospital before discharge - will visit the Outpatient Clinic of the MCA after discharge

Exclusion criteria

Exclusion criteria: - congenital abnormalities of the gastro-intestinal tract - cardiac abnormalities - metabolic or chromosomal/syndromal diseases - infants that develop necrotising enterocolitis stage IIb or III (NEC)

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint: To prospectively obtain the (parenteral/enteral) intake of protein, fat, carbohydrates and calories in 200 moderately preterm infants (32-36 weeks) and obtain prospectively growth data in the first 2 years of life. The main study parameter is to correlate the intake data with the postnatal growth data at the age of 2 years.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints: The intake and growth data will be compared with a Bayley Scales of Infant development (BSID-III) test at the age of 24 months to determine whether intake or growth in the first 2 years of life is a risk factor for an impaired motor or mental development. Thirdly, a body composition measurement at the age of 2 years will be performed to determine whether intake and growth in the first 2 years of life have an effect on body composition in moderately preterm infants. This could indicate whether these infants will be at risk for long term morbidities like the metabolic syndrome as described in extremely preterm infants. The goal is to obtain the Bayley scores of mental and motor development and the body composition of 100 moderately preterm infants.	—

Measure

Time frame

Secondary study parameters/endpoints: The intake and growth data will be compared with a Bayley Scales of Infant development (BSID-III) test at the age of 24 months to determine whether intake or growth in the first 2 years of life is a risk factor for an impaired motor or mental development. Thirdly, a body composition measurement at the age of 2 years will be performed to determine whether intake and growth in the first 2 years of life have an effect on body composition in moderately preterm infants. This could indicate whether these infants will be at risk for long term morbidities like the metabolic syndrome as described in extremely preterm infants. The goal is to obtain the Bayley scores of mental and motor development and the body composition of 100 moderately preterm infants.

—

Countries

Netherlands

Outcome results