Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-12-31

Brief Summary

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

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

Related Clinical Trials

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

Pulmonary Function During Prone and Supine Positioning in NICU Infants Requiring Assisted Ventilation

NCT00749762

Pulmonary Function

WITHDRAWN

Breathing Variability and NAVA in Neonates

NCT04000568

Neonatal Respiratory Distress Syndrome Prematurity

COMPLETED

Work of Breathing During Non-invasive Ventilation in Premature Neonates

NCT02788110

Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia

COMPLETED NA

Nasal Noninvasive NAVA in the Very Low Birth Weight Infant

NCT01785563

Inadequate; Pulmonary Ventilation, Newborn Infant, Very Low Birth Weight

COMPLETED NA

How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

NCT04659083

Premature Infants Neurally Adjusted Ventilatory Assist Ventilator Lung; Newborn +1 more

COMPLETED

Detailed Description

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

Conditions

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

Neonatal Oxygen Desaturation Premature Ventilator Lung; Newborn Apnea of Prematurity

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Prone positioning

Group Type EXPERIMENTAL

Body positioning

Intervention Type OTHER

Body positioning of infants prone vs supine.

Supine positioning

Group Type ACTIVE_COMPARATOR

Body positioning

Intervention Type OTHER

Body positioning of infants prone vs supine.

Interventions

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

Body positioning

Body positioning of infants prone vs supine.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
* Infant must be stable on NAVA for at least 24 hours prior to the study

Exclusion Criteria

* Infants with congenital heart disease (CHD)
* Infants with persistent pulmonary hypertension (PPHN)
* Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.

Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No