Skip to content

The Characterization of Intermittent Hypoxemia and Its Association with Sleep and Regulatory Behavior in Preterm Infants

The Characterization of Intermittent Hypoxemia and Its Association with Sleep and Regulatory Behavior in Preterm Infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040472
Enrollment
30
Registered
2026-06-11
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

intermittent hypoxemia

Interventions

Group 1: The study is designed as a prospective, monocentric, longitudinal, interventional pilot study. It will enroll 30 preterm infants with a gestational age of = 30 + 0 weeks. The aim of the study
no additional blood draws are performed specifically for this study. To assess regulatory behavior, parents are provided with standardized, modified questionnaires regarding their child's crying, fee

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Gestational age = 30 0/7

Exclusion criteria

Exclusion criteria: Major congenital anomalies or inherited metabolic diseases or chromosomal anomalies that may have an adverse effect on breathing or ventilation; infants with primary palliative care, families without sufficient knowledge of the German language to provide informed consent and fill out a questionnaire.

Design outcomes

Secondary

MeasureTime frame
- Association of intermittent hypoxemia episodes, abdominal contractions and noises with sleep stages - Quantification of external/ environmental factors in the NICU and their impact on intermittent hypoxemia (e.g. duration of bonding) - Stress burden, measured as blood cortisol levels - Evaluation of regulatory disorder problems (after discharge) in association with intermittent hypoxemia - Parental burden caused by behavioral mechanisms (i.e., “preemie grunts”)

Primary

MeasureTime frame
-Objective quantification and characterization of intermittent hypoxemia episodes and associated (vocal) sounds at two time points during hospitalization (postmenstrual age (PMA): 32 and 36 weeks) and at one time point after discharge (at 4 months corrected age) -Vocal classification of intermittent hypoxemia

Countries

Germany

Contacts

Public ContactLeonie Paciello und Kriszta Molnar

Universitätsklinikum Tübingen

leonie.paciello@med.uni-tuebingen.de070712999

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026