NCT04231630

Brief Summary

A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.

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
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

January 9, 2020

Last Update Submit

January 13, 2020

Conditions

Growth Delay

Outcome Measures

Primary Outcomes (1)

  • Growth

    Weight velocity

    through study completion, approximately 6 months

Secondary Outcomes (2)

  • Linear growth

    through study completion, approximately 6 months

  • Head circumference growth

    through study completion, approximately 6 months

Study Arms (1)

Observational Case

OTHER

1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.

Other: Prolacta

Interventions

ProlactaOTHER

Will receive outpatient supplementation with donor human milk product added to mother's own milk

Observational Case

Eligibility Criteria

Age6 Months - 1 Year
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dell Medical School

Austin, Texas, 78715, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 18, 2020

Study Start

November 20, 2019

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)