Work of Breathing in Premature Infants at Discharge

NCT ID: NCT03682575

Last Updated: 2023-04-18

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

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-10

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bronchopulmonary Dysplasia Very Low Birth Weight Infant Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)

Preterm infants who were on oxygen at 28 days of life.

Enrollment

Intervention Type OTHER

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.

Enrollment

Intervention Type OTHER

All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.

Interventions

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Enrollment

All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelley Z Kovatis, MD

Role: PRINCIPAL_INVESTIGATOR

ChristianaCare

Locations

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Christiana Care Health Services, Inc

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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DDD604122

Identifier Type: -

Identifier Source: org_study_id

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