Work of Breathing in Premature Infants at Discharge

April 14, 2023 updated by: Christiana Care Health Services

Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge

The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 7 months (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Preterm infants born greater than 26 weeks gestation, weighing less than 1500 grams at birth. Work of breathing indices will be compared between the group of babies who were diagnosed with BPD and the group that was not diagnosed with BPD.

Description

Inclusion Criteria:

  • Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth.
  • Infants with diagnosis of BPD and without diagnosis of BPD

Exclusion Criteria:

  • Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)
Preterm infants who were on oxygen at 28 days of life.
Other: Enrollment
All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.
Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD
Preterm infants who were not on oxygen at 28 days of life.
Other: Enrollment
All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work of breathing indices
Time Frame: 25 minutes
Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.
25 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermittent Hypoxia
Time Frame: 25 minutes
Oxygen saturation will be measured using a high resolution pulse oximeter.
25 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2020

Primary Completion (Actual)

November 17, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 24, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDD604122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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