NCT01850784

Brief Summary

High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

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

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

May 7, 2013

Last Update Submit

May 8, 2013

Conditions

Growth FailureNeurodevelopmental Disorder

Keywords

Congenital heart disease, Growth,Neurodevelopment

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    6 weeks

Secondary Outcomes (1)

  • Neurodevelopmental evaluation

    18 months

Study Arms (2)

High energy formula

ACTIVE COMPARATOR

High energy formula (Similac)

Dietary Supplement: High energy formula

Standard formula

ACTIVE COMPARATOR

Standard formula

Dietary Supplement: Standard formula

Interventions

High energy formulaDIETARY_SUPPLEMENT

The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)

Also known as: High energy formula (Similac)
High energy formula
Standard formulaDIETARY_SUPPLEMENT

The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)

Standard formula

Eligibility Criteria

Age8 Days - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants \>35 weeks of gestational age
  • infants with CHD
  • İnfants fed with formula feeding

You may not qualify if:

  • Major congenital abnormalities except CHD
  • infants could not be fed enterally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sami Ulus CH

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Failure to ThriveNeurodevelopmental DisordersHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMental DisordersCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dilek Dilli

    Sami Ulus CH

    STUDY DIRECTOR

Central Study Contacts

Dilek Dilli, Assoc Prof

CONTACT

00903126243dilekdilli2@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 9, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

TU(1)