NCT02603796

Brief Summary

Facial scans of newborns will be performed before and after implementation of respiratory support devices such as nasal CPAP. 3D scanned images will be processed by Fisher \& Paykel Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

October 30, 2015

Last Update Submit

July 22, 2016

Conditions

Nose Deformities, Acquired

Keywords

3-Dimensionalcontinuous positive airway pressurenasal changes

Outcome Measures

Primary Outcomes (1)

  • Deformation changes in nares of preterm infants that require ncpap

    3D scans of infants face will be performed before implementation of NCPAP and a 3D scan will be performed after the NCPAP is discontinued and the images will be analyzed for changes in facial structures that might be due to NCPAP.

    Up to 6 months

Other Outcomes (5)

  • Gestational Age at time of CPAP

    Up to 6 months

  • Photograph of nose with scaled ruler

    Up to 6 months

  • Initial 3D scan

    Up to 6 months

  • +2 more other outcomes

Study Arms (1)

Newborns requiring ncpap

3D scan of nares will be performed before and after administration of NCPAP for infants with Corrected Gestational Age greater than or equal to 24 weeks and less than or equal to 42 weeks.

Other: 3D Scan of nares

Interventions

3D Scan of naresOTHER

3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.

Newborns requiring ncpap

Eligibility Criteria

Age24 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants between 24 and 42 weeks corrected gestational age and admitted to Sharp Mary Birch NICU.

You may qualify if:

  • Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU,
  • Signed informed consent form

You may not qualify if:

  • Nasally intubated infants
  • Infants with craniofacial abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Nose Deformities, Acquired

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neonatal Research

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 13, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations

US(1)