Impact of noise to intermittent hypoxia and bradycardia in preterm infants. A randomized controlled trial

Impact of noise to intermittent hypoxia and bradycardia in preterm infants. A randomized controlled trial - NAOP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003433

Enrollment

Registered

2012-05-10

Start date

2012-05-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

R06.8 P07.2

Interventions

Group 1: cross-over design: MiniMuffs® as an ear protection then no intervention Group 2: cross-over design: no intervention then MiniMuffs® as an ear protection

Eligibility

Sex/Gender

All

Age

24 Weeks to 37 Weeks

Inclusion criteria

Inclusion criteria: Patients of the local neonatal intensive care unit; presentation of apnea of prematurity; parents agreement

Exclusion criteria

Exclusion criteria: Redemtion of the parents agreement

Design outcomes

Primary

Measure	Time frame
Occurrence of pulse oximeter saturation below 80% per h, measurements last 2 h with and 2 h without intervention (ear protection).	—

Secondary

Measure	Time frame
Occurrence of heart beat under 80 beate per minute per h, measurements last 2 h with and 2 h without intervention (ear protection).	—

Countries

Germany

Contacts

Public ContactThomas Sebastian Bott

Universitätsklinik für Kinder- und Jugendmedizin; Abt. IV Neonaologie

thomas-s.bott@uni-tuebingen.de0178/3260126

Outcome results

None listed

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