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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833818
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Britt Nakstad, University Hospital, Akershus
  Purpose
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.

Condition Intervention
Perinatal Disorders of Growth and Development Dietary Supplement: CAKE-intervention Dietary Supplement: CAKE-control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Growth and Development of Premature Babies

Resource links provided by NLM:


Further study details as provided by Britt Nakstad, University Hospital, Akershus:

Primary Outcome Measures:
  • 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 .


Estimated Enrollment: 200
Study Start Date: November 2015
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospital, Akershus
Investigators
Study Director: Britt Nakstad, PhD MD Project leader
  More Information

Responsible Party: Britt Nakstad, professor, neonatologist, Head of section for Research at Dept Paediatrics, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02833818     History of Changes
Other Study ID Numbers: AkershusUH
First Submitted: January 11, 2016
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided