Monitoring lung fluid clearance and aeration during pulmonary transition after birth

Withdrawn

Conditions: lungaeration
Newborns
10028971

Registration Number: NL-OMON43044

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

o Gestational age 25 * 42 weeks
o Written informed consent from both parents or legal representatives

Exclusion Criteria

o Postmenstrual age < 25 weeks
o Birth weight < 600 g
o Chest skin lesions preventing placement of electrode belt
o Acute and severe fetal distress with anticipated need for resuscitation after birth

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study parameters/endpoints<br /><br>Main study parameter/endpoint<br /><br>1. The change in lung aeration in the first 60 minutes after birth assessed by:<br /><br>a. End-expiratory lung volume (*EELV)<br /><br>b. Absolute tidal volume<br /><br>c. Tidal volume distribution<br /><br><br /><br>2. The regional distribution of these changes in EELV and tidal volume<br /><br>distribution assessed by:<br /><br>a. Left to right lung ratio<br /><br>b. Dependent to non-dependent lung ratio<br /><br>c. Geometric Center of Ventilation (CoV)<br /><br>d. Silent spaces or percentage atelectasis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Assess possible differences between the timing of lung aeration between term<br /><br>and preterm infants based on short and long time constants (*)<br /><br>2. Assess possible differences between the timing of lung aeration between<br /><br>infants born via the vaginal route and those born via caesarian section<br /><br>3. Assess the association between changes in lung aeration and the vital<br /><br>parameters heart rate and oxygen saturation measured with pulse oximetry<br /><br>(SpO2). In a subgroup of patients, we will also assess the association between<br /><br>lung aeration and airway pressure and volume (see study procedure).</p><br>