CClinicalTrials.gg
Status unknownNCT04209088PREDYSPEUpdated Jun 1, 2022

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

An interventional study of Pulmonary ultrasounds in Bronchopulmonary Dysplasia, sponsored by University Hospital, Limoges. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Not applicable
Sex
All
01

Study 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).

02

Conditions studied

  • Bronchopulmonary Dysplasia

Keywords

  • bronchopulmonary dysplasia
  • premature newborn
  • ultrasonography
03

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's planned enrollment of 218 is above the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Cardiac malformations
  • Congenital lung malformation.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
218 participants (estimated)

Study arms

  • Experimental
    Pulmonary ultrasounds

    All patients will be included in the experimental arm

    Other: Pulmonary ultrasounds

Interventions

  • OtherPulmonary ultrasounds

    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.

06

What researchers measure

Primary outcomes

  1. Evaluate the AUC of the modified LUS score to predict the occurrence of BPD

    Time frame: Day 9

Secondary outcomes

  1. Evaluate the AUC of the modified LUS score to predict the occurrence of BPD

    Time frame: Day 15

  2. Concordance of measured LUS scores between operator and reviewer

    Time frame: Day 9

  3. Concordance of measured LUS scores between operator and reviewer

    Time frame: Day 15

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04209088
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
May 29, 2020
Primary completion
Jun 6, 2023 (estimated)
Completion
Jun 6, 2023 (estimated)
Last update
Jun 1, 2022

Study contacts

Pauline HANGARD, Doctor
Contact
pauline.hangard@chu-limoges.fr
+33 (0) 555 058 666
Laure PONTHIER, Doctor
Contact
laure.ponthier@chu-limoges.fr
+33 (0) 555 058 666

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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