NCT02833818

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

11.4 years

First QC Date

January 11, 2016

Last Update Submit

January 29, 2021

Conditions

Perinatal Disorders of Growth and Development

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

CAKE-intervention

EXPERIMENTAL

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

CAKE-control

ACTIVE COMPARATOR

nutrition according to established procedures in the neonatal intensive care unit (NICU)

Dietary Supplement: CAKE-control

Interventions

CAKE-interventionDIETARY_SUPPLEMENT

Increased protein and energy supplementation and conversations

Also known as: clinical nutritionist, high protein and energy
CAKE-intervention
CAKE-controlDIETARY_SUPPLEMENT

nutrition according to established procedures

CAKE-control

Eligibility Criteria

Age26 Weeks - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Birth weight below 1500 and above 2000g.
  • Invasive catheters or ventilator.
  • Malformations or chromosomal disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Britt Nakstad, PhD MD

    Project leader

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr. Elin Wahl Blakstad

Study Record Dates

First Submitted

January 11, 2016

First Posted

July 14, 2016

Study Start

October 1, 2010

Primary Completion

February 20, 2022

Study Completion

February 20, 2022

Last Updated

February 2, 2021

Record last verified: 2021-01