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Monitoring lung fluid clearance and aeration during pulmonary transition after birth

Monitoring lung fluid clearance and aeration during pulmonary transition after birth - Lung fluid clearance and aeration during pulmonary transition after birth

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43044
Enrollment
120
Registered
2017-01-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lungaeration Newborns

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: o Postmenstrual age

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)