Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g (CAKE)

Elin Wahl Blakstad

Status: Unknown

Conditions: Perinatal Disorders of Growth and Development

Treatments: Dietary Supplement: CAKE-intervention; Dietary Supplement: CAKE-control

Study type: Interventional

Funder types: Other

Identifiers

NCT02833818

AkershusUH

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 26 to 35 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

CAKE-intervention

Experimental group

Description:

Increased nutrition and dietary consultations. Growth rate followed by clinical nutritionists that supply high protein and energy if growth rate deviates from 17g/kg/day

Treatment:

Dietary Supplement: CAKE-intervention

CAKE-control

Active Comparator group

Description:

nutrition according to established procedures in the neonatal intensive care unit (NICU)

Treatment:

Dietary Supplement: CAKE-control