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

Growth and Development of Premature Babies

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.

Study Overview

• Status: Unknown
• Conditions: Perinatal Disorders of Growth and Development
• Intervention / Treatment: Dietary supplement: CAKE-intervention; Dietary supplement: CAKE-control

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAKE-intervention; 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 Names: 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

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

Collaborators and Investigators

• Sponsor: Elin Wahl Blakstad
• Investigators: Study Director: Britt Nakstad, PhD MD, Project leader

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Anticipated): February 20, 2022
• Study Completion (Anticipated): February 20, 2022

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AkershusUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED