Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm 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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-15

Study Completion Date

2030-07-01

Brief Summary

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

Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.

Related Clinical Trials

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

Measuring Oxygenation of Newborn Infants in Targeted Oxygen Ranges

NCT03360292

Premature Infant Hypoxia Hyperoxia

COMPLETED NA

Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

NCT01460576

Preterm Birth Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity

COMPLETED

Prematurity-Related Ventilatory Control

NCT03464396

Respiratory Control in Premature Infants

COMPLETED

Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension

NCT04938167

Persistent Pulmonary Hypertension of the Newborn Hypoxemic Respiratory Failure

ACTIVE_NOT_RECRUITING NA

Physiologic Definition of Bronchopulmonary Dysplasia

NCT01223287

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +2 more

COMPLETED

Detailed Description

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

Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention).

Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. Reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.

Conditions

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

Bronchopulmonary Dysplasia Pulmonary Hypertension

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 1 week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed.

Study Groups

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

Oxygen saturation target 92-95%

At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 92-95% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed to a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.

Group Type ACTIVE_COMPARATOR

lower oxygen saturation target using Nellcor pulse oximetry sensors

Intervention Type DEVICE

The intervention will be a cross over exposure to the lower oxygen saturation target.

Oxygen saturation target 95-98%

At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 95-98% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed for a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.

Group Type ACTIVE_COMPARATOR

higher oxygen saturation target using Nellcor pulse oximetry sensors

Intervention Type DEVICE

The intervention will be a cross over exposure to the higher oxygen saturation target.

Interventions

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

higher oxygen saturation target using Nellcor pulse oximetry sensors

The intervention will be a cross over exposure to the higher oxygen saturation target.

Intervention Type DEVICE

lower oxygen saturation target using Nellcor pulse oximetry sensors

The intervention will be a cross over exposure to the lower oxygen saturation target.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Between 22w 0/7d and 31w 6/7d gestation at birth
* Diagnosed with echocardiographic pulmonary hypertension (1) \>20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index \>1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg
* Receiving supplemental oxygen
* Have mature retinas