MedDataX Logo

3D Imaging of Neonatal Faces

NCT ID: NCT02603796

Last Updated: 2016-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physiological Changes With High-Flow Nasal Cannula

NCT03700606

Respiratory Distress Syndrome in Premature Infant
COMPLETED NA

Airway Pressure During Nasal High Flow and CPAP in Neonates

NCT02632799

Respiratory Insufficiency
COMPLETED NA

Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment

NCT03586856

Respiration; Insufficient or Poor, Newborn Infant,Premature
COMPLETED NA

Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

NCT03711565

Neonatal Respiratory Distress Related Conditions
WITHDRAWN NA

Nasal Problems in Neonates and Infants Subjected to CPAP

NCT06557915

Continuous Positive Airway Pressure
NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nose Deformities, Acquired

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

3D Scan of nares

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3D Scan of nares

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role collaborator

Sharp HealthCare

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anup Katheria, M.D.

Director of Neonatal Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3D Imaging in neonates

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP
NCT01939067 WITHDRAWN PHASE1
Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates
NCT06038565 WITHDRAWN NA
Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)
NCT00636324 TERMINATED PHASE2
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
NCT02168257 TERMINATED NA
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
NCT03706976 COMPLETED NA
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
NCT01270581 TERMINATED NA
nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS
NCT02772835 COMPLETED NA
Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants
NCT01326975 COMPLETED
Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
NCT06579157 RECRUITING
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
NCT02126501 COMPLETED NA
Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
NCT01093495 COMPLETED NA
Feasibility of Using the Neovent in Low-Resource Settings
NCT06697951 RECRUITING NA
Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
NCT05965830 RECRUITING
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
NCT01277874 WITHDRAWN NA
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
NCT01531465 COMPLETED NA
MRI in BPD Subjects
NCT03657693 RECRUITING
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
NCT01859533 COMPLETED PHASE2
Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
NCT06966752 RECRUITING NA
Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates
NCT06737003 COMPLETED NA
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
NCT05968586 COMPLETED NA
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
NCT06295484 RECRUITING NA
Non-invasive Ventilation in Preterm Infants
NCT05987800 ACTIVE_NOT_RECRUITING NA
Work of Breathing During Non-invasive Ventilation in Premature Neonates
NCT02788110 COMPLETED NA
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
NCT03292562 COMPLETED NA
Ventilatory Management of the Preterm Neonate in the Delivery Room
NCT01255826 COMPLETED PHASE2