Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiac Disease Neonatal Disease Post-Surgical Complication

Keywords

Recovery

Outcome Measures

Primary Outcomes (1)

To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD
A comparison of feeding patterns (oral cavity pressure changes in suck and swallow, and respiratory patterns) and changes as an infant recovers and determination if there is a greater than 60% concordance with behavioral survey measuring recovery.
12 months

Secondary Outcomes (1)

Comparison of Neoneur Feeding system measurements seen in post surgical infants, to match clinical observation of suck, swallow, and breathing during oral feeding.
12 months

Study Arms (1)

Feeding Assessment

EXPERIMENTAL

While Feeding, use Neoneur Feeding System to measure feeding patterns (suck, swallow, and breathing)

Device: Neoneur Feeding System

Interventions

Neoneur Feeding SystemDevice

The Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns.

Feeding Assessment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Day - 50 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Complex congenital heart disease requiring cardiac surgery during first month of life
Gestational age\>=35 weeks at birth

You may not qualify if:

Sponsors & Collaborators

Neoneur LLC
Industrylead

MeSH Terms

Conditions

Infant, Newborn, DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular Diseases

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 26, 2024

Study Start

September 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Feeding Assessment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Feeding Assessment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Source record