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the effect of earmuff on the preterm infants

The effects of earmuffs on the physiologic and behavioral responses in preterm infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015020817972N6
Enrollment
72
Registered
2015-05-17
Start date
2014-06-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

preterm infant. 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.

Interventions

intervention group: one day preterm infant with earmuff and one day without earmuff.
Prevention
intervention group: one day preterm infant with earmuff and one day without earmuff

Sponsors

Deputy of Research Tehran University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Days to 29 Days

Inclusion criteria

Inclusion criteria: inclusion criteria: preterm infant, age more than 7 day, need to care in incubator, normal audiometry, oral nutrition, no needs to use Anticonvulsants and Respiratory stimulant drugs, without congenital ear infections and other congenital anomaly, The absence of hemodynamic instability during the first week after birth, without intra ventricular hemorrhage, exclusion criteria: infant death, life threatening emergency condition, refuse parents to participate in the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Respiratory rate. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: respiratory rate per min measured by monitor.;Heart rate. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: heart rate per min measured by monitor.;Oxigen saturation. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: with palsoximeter.;Body tempreture. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: santigrade degree.;Sistolic blood presure. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: mmhg.;Diastolic blood presure. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: mmhg.;Behavioral response. Timepoint: Q2h with earmuff and without earmuff. Method of measurement: abss score system.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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