Heart rate and Oxygen saturation in Term Infants Study

• Conditions: eonatale transitie problematiek; Neonatal transition problems; short-term drop in oxygen saturation and heart rate

• Registration Number: NL-OMON42428
• Lead Sponsor: Amphia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- Newborn infants in the first 6 hours of life
- Gestational age 35 weeks or above

Exclusion Criteria

- Gestational age <35 weeks
- Medical indication for monitoring vital signs
- Any known cardiac or chromosomal defect
- Any (antenatally or postnatally) suspected cardiac defect
- Absence of written informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints are the distribution and percentile scores of oxygen<br /><br>saturation and heart rate. Also the frequency and significance of desaturations<br /><br>and episodes of bradycardia are main endpoints</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of this study is to investigate the differences in<br /><br>normal ranges of vital signs between newborns with differences in obstetric<br /><br>history (i.e. caesarean delivery, small for gestational age, large for<br /><br>gestational age, late prematurity) and between periods of feeding and<br /><br>non-feeding.</p><br>