Work of Breathing in Premature Infants at Discharge

NCT03682575 | Completed

• 1 other identifier: DDD604122
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchopulmonary Dysplasia; Very Low Birth Weight Infant; Prematurity

Outcome Measures

Primary Outcomes (1)

• Work of breathing indices

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

  25 minutes

Secondary Outcomes (1)

• Intermittent Hypoxia

  25 minutes

Study Arms (2)

Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)

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

Other: Enrollment

Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD

Preterm infants who were not on oxygen at 28 days of life.

Other: Enrollment

Interventions

Enrollment OTHER

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

Infants WITH diagnosis of bronchopulmonary dysplasia (BPD); Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD

Eligibility Criteria

• Age: 1 Month - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Services, Inc

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kelley Z Kovatis, MD

  ChristianaCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: November 10, 2020
• Primary Completion: November 17, 2022
• Study Completion: February 28, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)