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

January 29, 2021 updated by: Elin Wahl Blakstad

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From birth until 4 months postmenstrual age (PMA)
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
Time Frame: From birth until 4 months PMA
Eating habits at discharge/term and at 4 months PMA .
From birth until 4 months PMA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elin Wahl Blakstad

Investigators

  • Study Director: Britt Nakstad, PhD MD, project leader

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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