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Completed

NCT Number: NCT03682575

Work of Breathing in Premature Infants at 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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury Very Low Birth Weight Infant

Age range

1 month–7 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Services, Inc

Newark, Delaware, 19718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enrollment

Other

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

Primary outcomes

  1. Work of breathing indices

    Time frame: 25 minutes

    Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.

Secondary outcomes

  1. Intermittent Hypoxia

    Time frame: 25 minutes

    Oxygen saturation will be measured using a high resolution pulse oximeter.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 24, 2018
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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