NCT02389491

Brief Summary

The purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

February 5, 2015

Last Update Submit

November 9, 2015

Conditions

Congenital Heart Disease

Keywords

high density formulaheart defectsinfant

Outcome Measures

Primary Outcomes (2)

  • weight gain at the 7th day (g)

    the 7th day body weight minus baseline body weight

    from the first day starting enteric feeding to the 7th days

  • the number of participants with feeding intolerance

    Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.

    from the first day starting enteric feeding to the 7th day

Secondary Outcomes (4)

  • Duration of mechanical ventilation

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • length of Cardiac Intensive Care Unit(CCU) stay

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • the number of participants with poor wound healing

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • the number of participants with necrotizing enterocolitis

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

normal density formula (Neocate)

ACTIVE COMPARATOR

In control group,infants intake normal density formula (Neocate,67kcal/100ml) when starting enteral nutrition after operation and continue for 7days

Dietary Supplement: normal density formula (Necocate)

high density formula (Infatrini)

EXPERIMENTAL

In the intervention group,infants intake high density formula (Infatrini, 100kcal/100ml) when starting enteral nutrition after operation and continue for 7days

Dietary Supplement: high density formula(Infatrini)

Interventions

normal density formula (Necocate)DIETARY_SUPPLEMENT

In control group,there are 32 infants

normal density formula (Neocate)
high density formula(Infatrini)DIETARY_SUPPLEMENT

In intervention group,there are 32 infants

high density formula (Infatrini)

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination
  • aged from 1 day to 12 months
  • accept extracorporeal circulation open-heart surgery
  • family members voluntarily participate in this study

You may not qualify if:

  • patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction
  • accept total parenteral nutrition
  • predicted the length of CCU stay is less than five days
  • patients have abdominal distention, diarrhea, vomiting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gu Ying, docter

    Children Hospital of Fudan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11