Comparison of two different non-invasive ventilation strategies, non-invasive intermittent positive pressure ventilation (NIPPV) and continuous positive airway pressure (CPAP) in preterm infants using electrical impedance tomography (EIT), transcutaneous CO2 and O2 saturation measurement - a randomized clinical trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036954

Enrollment

Registered

2025-07-28

Start date

2025-08-29

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

P22.0

Interventions

Group 1: Premature babies (birth weight <1500g) who are treated in the neonatal intensive care unit at Giessen University Hospital and require non-invasive ventilation (CPAP/NIPPV) (FiO2 at 0.21-0.6 a

Eligibility

Sex/Gender

All

Age

3 Days to No maximum

Inclusion criteria

Inclusion criteria: 1.premature babies (birth weight <1500g) who are treated in the neonatal intensive care unit at Giessen University Hospital 2.need for non-invasive ventilation (CPAP/NIPPV) 3.FiO2 under CPAP/NIPPV at 0.21-0.6 with a PEEP of 5-8 cmH2O 4.at least 4 hypoxaemias (< 80% SpO2) and/or 4 apnoeas/bradycardias in 12 hours prior to study entry 5.written consent of the legal guardian has been obtained

Exclusion criteria

Exclusion criteria: 1.premature and newborn infants with severe malformations that significantly impair respiratory regulation (severe CNS malformations), lung function (e.g. lung hypoplasia, acute extra-alveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias) or circulatory function (congenital cyanotic heart disease, severe septic shock), as well as periventricular leukomalacia and intraventricular haemorrhage (grade III and IV) 2.postnatal age 10mg/l) with and without circulatory insufficiency or positive blood culture 4.anticipated blood transfusion or surgery during the study phase

Design outcomes

Primary

Measure	Time frame
The primary endpoints are absolute time as a percentage of pulse oximetry oxygen saturation (SpO2) in our oxygen saturation target range (88-95%), transcutaneous carbon dioxide (tcpCO2) values in the target range (35-45 mmHg) and non-invasive measurement of regional lung ventilation using EIT.	—

Secondary

Measure	Time frame
•Number and duration of episodes with SpO2 95% with oxygen demand during each study period •Number of long and very long hypoxic and hyperoxic episodes outside the target SpO2 range (defined as episodes lasting > 60 seconds and > 180 seconds) •Mean inspiratory oxygen concentration (FiO2) during each study period •Median and mean SpO2 values and SpO2 variability (coefficient of variation) during each study period •Measurement of cerebral tissue oxygenation (SctO2) Individual SctO2 median of each child during each study period Area under the curve above and below the individual SctO2 median of each child during each study period •Mean transcutaneous pCO2 and standard deviation during each study period •Silverman score (clinical scoring system to determine the degree of respiratory distress) at the beginning and end of the study period/blinding not possible •Number of children who fulfil the predefined discontinuation criteria at which point in time and in which study period •Assessment of lung ventilation and volumes using electrical impedance tomography (EIT)	—

Measure

Time frame

•Number and duration of episodes with SpO2 95% with oxygen demand during each study period •Number of long and very long hypoxic and hyperoxic episodes outside the target SpO2 range (defined as episodes lasting > 60 seconds and > 180 seconds) •Mean inspiratory oxygen concentration (FiO2) during each study period •Median and mean SpO2 values and SpO2 variability (coefficient of variation) during each study period •Measurement of cerebral tissue oxygenation (SctO2) Individual SctO2 median of each child during each study period Area under the curve above and below the individual SctO2 median of each child during each study period •Mean transcutaneous pCO2 and standard deviation during each study period •Silverman score (clinical scoring system to determine the degree of respiratory distress) at the beginning and end of the study period/blinding not possible •Number of children who fulfil the predefined discontinuation criteria at which point in time and in which study period •Assessment of lung ventilation and volumes using electrical impedance tomography (EIT)

—

Countries

Germany

Contacts

Public ContactRahel Schuler

Universitätskinderklinikum Gießen

Rahel.Schuler@paediat.med.uni-giessen.de+4964198543410

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026