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

Study Overview
=================
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

Official Title
-----------------
Growth and Development of Premature Babies

Conditions
-----------------
Perinatal Disorders of Growth and Development

Intervention / Treatment
-----------------
* Dietary Supplement: CAKE-intervention
* Dietary Supplement: CAKE-control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight between 1500 and 2000g. No invasive catheters or ventilator (wish homogeneous group). No malformations or chromosomal disorders. Parents give informed written consent Born at study hospitals Exclusion Criteria: Birth weight below 1500 and above 2000g. Invasive catheters or ventilator. Malformations or chromosomal disorders.

Ages Eligible for Study
-----------------
Minimum Age: 26 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAKE-intervention<br>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<br>* Increased protein and energy supplementation and conversations<br>* Other names: clinical nutritionist, high protein and energy;|
| Active Comparator: CAKE-control<br>nutrition according to established procedures in the neonatal intensive care unit (NICU) | Dietary Supplement: CAKE-control<br>* nutrition according to established procedures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth at 4 months corrected months age | Growth from birth, during hospital stay, at discharge/term and at 4 months PMA. | From birth until 4 months postmenstrual age (PMA) | 
| Breastfed, full or partly, and solid food at 4 months PMA | Eating habits at discharge/term and at 4 months PMA . | From birth until 4 months PMA |