NCT05525091

Brief Summary

Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

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 Jul 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2024

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

August 30, 2022

Last Update Submit

September 13, 2023

Conditions

Feeding PatternsFeeding; Difficult, NewbornFeeding Disorder Neonatal

Outcome Measures

Primary Outcomes (2)

  • Maturation

    Neoneur 200 measures are corelated to infant maturation in gestational age

    6 weeks of data collection

  • Telehealth functionality

    Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home

    6 months

Secondary Outcomes (1)

  • Respiratory

    6 months

Study Arms (1)

Feeding Assessment

EXPERIMENTAL

Feeding assessment of High-risk premature infants

Other: Feeding Evaluation

Interventions

Feeding EvaluationOTHER

Feeding Evaluation with Device

Also known as: Neoneur 200
Feeding Assessment

Eligibility Criteria

Age1 Day - 10 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =\<34 week, extubated by term
  • Infants with CHD: requiring surgery during the first month of life, gestational age \> 37 weeks

You may not qualify if:

  • Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of NEC
  • Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for \> 4 weeks, requiring additional surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 08534, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Barbara Medoff-Cooper, MSN, PhD

    Children's Hospital of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Hoedemaker, BS/MBA

CONTACT

9084004096choedemaker@neoneur.com

Karen Heart

CONTACT

choedemaker-pi@neoneur.com

Study Design

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

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

July 14, 2022

Primary Completion

August 14, 2024

Study Completion

September 14, 2024

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

the results will be available and we will seek publication

Locations

US(1)