Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g (CAKE)
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|ClinicalTrials.gov Identifier: NCT02833818|
Recruitment Status : Enrolling by invitation
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Disorders of Growth and Development||Dietary Supplement: CAKE-intervention Dietary Supplement: CAKE-control||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Growth and Development of Premature Babies|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2025|
|Estimated Study Completion Date :||November 2025|
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
Dietary Supplement: CAKE-intervention
Increased protein and energy supplementation and conversations
Other Name: clinical nutritionist, high protein and energy
Active Comparator: CAKE-control
nutrition according to established procedures in the neonatal intensive care unit (NICU)
Dietary Supplement: CAKE-control
nutrition according to established procedures
- Growth at 4 months corrected months age [ Time Frame: From birth until 4 months postmenstrual age (PMA) ]Growth from birth, during hospital stay, at discharge/term and at 4 months PMA.
- Breastfed, full or partly, and solid food at 4 months PMA [ Time Frame: From birth until 4 months PMA ]Eating habits at discharge/term and at 4 months PMA .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833818
|Study Director:||Britt Nakstad, PhD MD||Project leader|