Effects of different inspiratory times on oxygenation and ventilation parameters in preterm infants with frequent fluctuations in arterial oxygen saturations - a randomized controlled trial

Effects of different inspiratory times on oxygenation and ventilation parameters in preterm infants with frequent fluctuations in arterial oxygen saturations - a randomized controlled trial - Not applicable

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023923

Enrollment

Registered

2020-12-28

Start date

2020-08-10

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Apnea of Prematurity

Interventions

Group 1: Use of prolonged inspiratory time during nasal intermittent positive pressure ventilation in preterm infants with frequent desaturation in arterial oxygen saturation Group 2: Use of shortenen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. premature infants (birth weight <1500g) who are treated in the neonatal intensive care unit or the intermediate care area 2. need of non-invasive ventilation (CPAP/NIPPV) 3. at least 4 hypoxemias (< 80% SpO2) or 4 apneas/bradycardias in 8 hours before study entry 4. written informed consent from legal guardians has been obtained

Exclusion criteria

Exclusion criteria: 1. premature and newborn infants with severe malformations that significantly affect respiratory regulation (severe CNS malformations), pulmonary function (e.g., pulmonary hypoplasia, acute extraalveolar air such as pneumothorax and pulmonary interstitial emphysema, diaphragmatic hernias), or circulatory function (congenital cyanotic cardiac disease, severe septic shock) 2. postnatal age 10mg/l) with or without circulatory insufficiency, or positive blood culture 4. Anticipated blood transfusion during the study phase

Design outcomes

Primary

Measure	Time frame
Time (percentage) the preterm infants spent within his specific SpO2- target range.	—

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, respectively) • Mean inspiratory air oxygen concentration (FiO2) during each study period. • Median and mean SpO2 values and SpO2 variability (coefficient of variation) during each study period • Number of apnea episodes lasting > 10 seconds during each study episode • Measurement of cerebral tissue oxygenation (SctO2) • Individual median SctO2 of each child during each study period. • Area under the curve above and below each child's individual median SctO2 during each study period • Mean transcutaneous pCO2/ paO2 and standard deviation during each study period. • Measurement of regional lung ventilation by electronic impedance tomography • Silverman score (clinical scoring system to determine the degree of respiratory distress) 4 times (every 6 h) per study period • Abdominal circumference measurement at the beginning after 24h and at the end of the study period respectively • Number of children meeting the predefined discontinuation criteria at which time point and in which study period	—

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, respectively) • Mean inspiratory air oxygen concentration (FiO2) during each study period. • Median and mean SpO2 values and SpO2 variability (coefficient of variation) during each study period • Number of apnea episodes lasting > 10 seconds during each study episode • Measurement of cerebral tissue oxygenation (SctO2) • Individual median SctO2 of each child during each study period. • Area under the curve above and below each child's individual median SctO2 during each study period • Mean transcutaneous pCO2/ paO2 and standard deviation during each study period. • Measurement of regional lung ventilation by electronic impedance tomography • Silverman score (clinical scoring system to determine the degree of respiratory distress) 4 times (every 6 h) per study period • Abdominal circumference measurement at the beginning after 24h and at the end of the study period respectively • Number of children meeting the predefined discontinuation criteria at which time point and in which study period

—

Countries

Germany

Contacts

Public ContactMarkus Waitz

Abteilung Allgemeine Pädiatrie und Neonatologie

markus.waitz@paediat.med.uni-giessen.de064198556100

Outcome results

None listed

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