Effect of Intensive Dietary Intervention in Children With... | NCT02833818

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

NCT02833818

Sponsor

Elin Wahl Blakstad

Status

Unknown status

Last Update Posted

Feb 2, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Perinatal Disorders of Growth and Development

Interventions

CAKE-intervention
CAKE-control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010Actual

Primary Completion Date

Feb 20, 2022Estimated

Completion Date

Feb 20, 2022Estimated

First Submitted Date

Jan 11, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elin Wahl Blakstad, dr. Elin Wahl Blakstad, University Hospital, AkershusSponsor-Investigator

Lead Sponsor

Elin Wahl BlakstadOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CAKE-intervention	Dietary Supplement	Increased protein and energy supplementation and conversations	CAKE-intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Weeks

Maximum Age

35 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Britt Nakstad, PhD MD	Project leader	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided