Clinical trial NCT02833818: Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g
Official title: Growth and Development of Premature Babies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perinatal Disorders of Growth and Development
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 26
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are few scientific reports on preterm infants with birth weights between 1500 and 2000g. Adequate and properly balanced supply of nutrients believed to better growth and cognitive development in this patient group, and optimized nutrition is an important part of treatment There is a need for more studies that can provide knowledge of growth and weight development in preterm and small for gestational age (SGA) infants with a birth weight between 1500 and 2000g.

Detailed description: There has been little focus, at least there are few scientific reports on preterm infants with birth weights between 1500 and 2000g, at least in Norway. Studies have shown the benefit of enhanced protein and energy supplements in very low birth weight infants (VLBW, birth weight \< 1500g), regarding growth and neurodevelopment . Adequate and properly balanced supply of nutrients is believed to give better growth and cognitive development in premature infants with slightly higher birth weight, i.e between 1500 and 2000g (1). In an intervention study of VLBW children at four Norwegian hospitals we found lower supply of energy and protein than international recommendations (2). A larger proportion of premature children were stunted growth (weight below 10 percentile for age) during hospitalization. Although this applies to preterm infants with birth weight less than 1500 g, this may also be the case for larger premature patients.

More studies that can provide knowledge of growth rate, weight and neurodevelopmental outcomes in preterm and small for gestational age (SGA) infants are warranted. This study examines those with birth weight between 1500 and 2000g. Overall, this may provide new and useful knowledge that can help to optimize the nutrition to preterm and SGA infants with a this range of birth weights

Eligibility criteria: Inclusion Criteria:

1. Birth weight between 1500 and 2000g.
2. No invasive catheters or ventilator (wish homogeneous group).
3. No malformations or chromosomal disorders.
4. Parents give informed written consent
5. Born at study hospitals

Exclusion Criteria:

1. Birth weight below 1500 and above 2000g.
2. Invasive catheters or ventilator.
3. Malformations or chromosomal disorders.

Primary outcomes:
measure: Growth at 4 months corrected months age
timeFrame: From birth until 4 months postmenstrual age (PMA)
measure: Breastfed, full or partly, and solid food at 4 months PMA
timeFrame: From birth until 4 months PMA
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Project leader
name: Britt Nakstad, PhD MD
role: STUDY_DIRECTOR
References: