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OpenTrials
Completed

NCT Number: NCT02603796

3D Imaging of Neonatal Faces

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.

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Key information

Conditions

Nose Deformities, Acquired Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

24 week–42 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

Any newborns admitted to the neonatal intensive care unit at Sharp Mary Birch Hospital for Women and Newborns between 24-42 weeks CGA with parental informed consent are eligible. 3D scanned image will be obtained prior to implementation of nasal support devices and after nasal support devices. Fisher & Paykel Healthcare Limited will analyze the 3D images and observations will be made for changes in nasal structure or distortion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Nasally intubated infants
  • Infants with craniofacial abnormalities

Treatment and study plan

3D Scan of nares

Other

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

Primary outcomes

  1. Deformation changes in nares of preterm infants that require ncpap

    Time frame: Up to 6 months

    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.

Other outcomes

  1. Gestational Age at time of CPAP

    Time frame: Up to 6 months

  2. Photograph of nose with scaled ruler

    Time frame: Up to 6 months

  3. Initial 3D scan

    Time frame: Up to 6 months

    Date & time of scan, head circumference, CGA, current weight, nasal integrity

  4. Post ncpap 3D scan

    Time frame: Up to 6 months

    Date & time of scan, head circumference, CGA, current weight, nasal integrity and/ or any notable distortion

  5. Total duration of ncpap days

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

3D Imaging of Neonatal Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2015
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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