Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation

NCT04209088 | Unknown

• 1 other identifier: 87RI19_0023 (PREDYSPE)
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

Each year, between 50,000 and 60,000 children are born prematurely in France. Among them, 10% are born at 26 - 30 week's gestation and 5% are born before 26 week's gestation. Bronchopulmonary dysplasia (BPD) affects at least one-quarter of infants born with a birth weight less than 1500 grams. BPD is defined by the need for oxygen after 28 days of life in any children born prematurely. In addition, the severity of BPD can be categorized as mild (room air tolerated at 36 weeks), moderate (oxygen requirement between 22 and 29 %) and severe (oxygen requirement 30% or need for ventilation support). Bronchopulmonary dysplasia is responsible for significant respiratory morbidity and impaired neurological outcomes. Pulmonary imaging such as tomodensitometry, MRI or scintigraphy can be abnormal and therefore coud theorically be helpful for an early diagnosis. Unfortunatelly, theses examinations are irradiating, expensive or difficult to perform in an everyday practice. Therefore lung imaging for BPD diagnosis. Is not recommanded in current official guidelines. Pulmonary ultrasound has already been studied in premature newborns. A pilot study carried out on 21 patients showed that pulmonary ultrasonography at one and two weeks of life could predict the risk of bronchopulmonary dysplasia. The score used in this study was the LUS score previously validated by Brat et al. Advantages of this examination are to be non-invasive and easily performed at the patient's bedside. Nevertheless this study focused on a small population with a low number of moderate / severe dysplasia. In addition, Czernik et al. have highlighted that the index of myocardial performance of the right ventricle was increased at seven and ten days of life in children who subsequently developed BPD. The investigators propose in this study to evaluate a new prediction score for DBP, the modified LUS score, associating the LUS score with an echographic evaluation of the right heart (myocardial performance index).

Conditions

Bronchopulmonary Dysplasia

Keywords

bronchopulmonary dysplasia; premature newborn; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Evaluate the AUC of the modified LUS score to predict the occurrence of BPD

  Day 9

Secondary Outcomes (3)

• Evaluate the AUC of the modified LUS score to predict the occurrence of BPD

  Day 15

• Concordance of measured LUS scores between operator and reviewer

  Day 9

• Concordance of measured LUS scores between operator and reviewer

  Day 15

Study Arms (1)

Pulmonary ultrasounds

EXPERIMENTAL

All patients will be included in the experimental arm

Other: Pulmonary ultrasounds

Interventions

Pulmonary ultrasounds OTHER

Two ultrasounds will be performed by the same pediatrician for each child included: the first at nine days of life +/- two days, the second at fifteen days of life +/- two days. A blind replay of ultrasound images to calculate the score will be performed by a another investigator.

Pulmonary ultrasounds

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premature neonates with gestational age less than or equal to 34 weeks of amenorrhea.
• Hospitalized in the NICU or neanatology unit at Limoges University Hospital at day 9 +/- 2 and day 15 +/- 2 of life
• participation agreement of at least one of the parents.

You may not qualify if:

• Cardiac malformations
• Congenital lung malformation.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital

Limoges, 87042, France

RECRUITING

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

Central Study Contacts

Pauline HANGARD, Doctor

CONTACT

+33 (0) 555 058 666; pauline.hangard@chu-limoges.fr

Laure PONTHIER, Doctor

CONTACT

+33 (0) 555 058 666; laure.ponthier@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: May 29, 2020
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)