NCT04359134

Brief Summary

Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth. A failure of the rapid reuptake of fetal lung fluids after birth, with subsequent liquid retention in the alveolar space, together with the deficit of surfactant proteins ensuing from lung immaturity represent the leading mechanisms for the development of RDS, which may require different levels of respiratory support. An increasingly used method for the evaluation of the neonatal lung is pulmonary ultrasound, which allows assessing alveolar fluids and other pathological conditions in a non-invasive manner, and has been shown to predict the need for respiratory support and for surfactant administration in preterm infants with RDS. However, this method requires specific training, is operator-dependent and does not provide a trend able assessment over time. Transthoracic electrical bioimpedance (TEB) allows continuous and non-invasive monitoring of static and dynamic thoracic fluids. It has been recently introduced in neonatal clinical practice to assess such hemodynamic parameters as cardiac output and also quantifies static thoracic fluids contents (TFC). This method provides continuous and non-operator dependent data on the pulmonary fluid status over time and does not require specific training. The combination of lung ultrasound with TEB could open to new diagnostic and prognostic perspectives in preterm infants with RDS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

April 17, 2020

Last Update Submit

July 26, 2021

Conditions

Respiratory Distress Syndrome in Premature InfantPatent Ductus Arteriosus After Premature BirthPerinatal Morbidity

Keywords

respiratory distresspatent ductus arteriosuspreterm infantstransthoracic electrical bioimpedancelung ultrasounds

Outcome Measures

Primary Outcomes (9)

  • Correlation between lung ultrasound score and RDS evolution

    Pearson correlation analysis between the score of lung ultrasound and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

    0-24 hours of life

  • Correlation between lung ultrasound score and RDS evolution

    Pearson correlation analysis between the score of lung ultrasound and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

    24-48 hours of life

  • Correlation between lung ultrasound score and RDS evolution

    Pearson correlation analysis between the score of lung ultrasound and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

    48-72 hours of life

  • Correlation between TFC and RDS evolution

    Pearson correlation analysis between TFC values and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

    0-24 hours of life

  • Correlation between TFC and RDS evolution

    Pearson correlation analysis between TFC values and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

    24-48 hours of life

  • Correlation between TFC and RDS evolution

    Pearson correlation analysis between TFC values and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

    48-72 hours of life

  • Correlation between TFC and lung ultrasound score

    Pearson correlation analysis between TFC values and lung ultrasound score

    0-24 hours of life

  • Correlation between TFC and lung ultrasound score

    Pearson correlation analysis between TFC values and lung ultrasound score

    24-48 hours of life

  • Correlation between TFC and lung ultrasound score

    Pearson correlation analysis between TFC values and lung ultrasound score

    48-72 hours of life

Secondary Outcomes (1)

  • Changes in TFC values and lung ultrasound score between time periods with patent and closed ductus arteriosus

    0-72 hours of life

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants ≤34 weeks' gestation with respiratory dystress

You may qualify if:

  • hours of life,
  • gestational age ≤34 weeks' gestation
  • diagnosis of respiratory distress
  • written informed consent obtained from parents/legal guardians of each infant.

You may not qualify if:

  • major congenital malformations, including congenital heart disease
  • meconium aspiration
  • pneumothorax
  • perinatal asphyxia/hypoxic-ischemic encephalopathy
  • concomitant use of experimental drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

S. Orsola-Malpighi University Hospital

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Niguarda Hospital

Milan, Italy

RECRUITING

MeSH Terms

Conditions

DyspneaDuctus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Silvia Galletti

    Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Galletti

CONTACT

0039 051 2144774silvia.galletti4@unibo.it

Silvia Martini

CONTACT

0039 051 2144774silvia.martini9@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Researcher

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 24, 2020

Study Start

March 10, 2020

Primary Completion

March 31, 2022

Study Completion

April 5, 2022

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

IT(2)