An interventional study of Neonatal Earmuffs in Preterm Infants, sponsored by University of Baghdad. Not yet recruiting at 1 site in Iraq. Open to participants aged 1 Day to 14 Days. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Baghdad · Not applicable, Interventional, and Supportive care
This study aims to evaluate the effect of earmuffs on physiological stability, sleep-wake states, and weight gain in preterm neonates admitted to neonatal intensive care units (NICUs). The study will compare preterm neonates receiving earmuffs in addition to routine nursing care with those receiving routine nursing care alone. Physiological stability will be assessed by measuring heart rate, respiratory rate, oxygen saturation, and body temperature. Sleep-wake states will be assessed using the Anderson Behavioral State Scoring (ABSS) system, and weight gain will be evaluated through body-weight measurements. The study may provide evidence on the potential role of earmuffs as a supportive nursing intervention for preterm neonates.
Preterm neonates admitted to neonatal intensive care units (NICUs) may be exposed to environmental noise generated by monitoring devices, alarms, respiratory support equipment, and routine staff activities. Because preterm neonates have immature physiological and neurological systems, protecting their developmental environment is an important aspect of neonatal supportive care.
Earmuffs may help reduce neonates' exposure to environmental noise. However, their effects on physiological stability, sleep-wake states, and weight gain need further evaluation. This study will investigate these outcomes to contribute evidence on the potential role of earmuffs in supportive nursing care for preterm neonates.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
This study's planned enrollment of 80 is close to the median of 84 across 1,669 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Baghdad is the lead sponsor of 171 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Preterm neonates receive earmuffs in addition to routine nursing care.
Device: Neonatal Earmuffs
Preterm neonates receive routine nursing care alone, without the earmuff intervention.
External neonatal earmuffs will be used as a non-pharmacological intervention to reduce preterm neonates' exposure to environmental noise in the neonatal intensive care unit. The earmuffs will be applied according to the manufacturer's instructions and the study protocol. The intervention group will receive earmuffs in addition to routine neonatal care.
Sleep-Wake States in Preterm Neonates
(ABSS) system.Sleep-wake states will be assessed using the Anderson Behavioral State Scale (ABSS). The scale ranges from 1 to 12. Scores from 1-4 indicate sleep states, 5-7 indicate awake states, and 8-12 indicate restless states. Higher scores indicate a worse outcome (more restless/fussy), while lower scores indicate a better outcome (deep sleep).
Time frame: Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
Heart Rate in Preterm Neonates
Heart rate will be measured in beats per minute (bpm) using a pulse oximeter.
Time frame: Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
Respiratory Rate in Preterm Neonates
Respiratory rate will be measured by direct observation for one minute (counting breaths per minute).
Time frame: intervention.Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
Oxygen Saturation (SpO2) in Preterm Neonates
Oxygen saturation will be measured as a percentage (%) using a pulse oximeter.
Time frame: Daily for 5 days (each daily intervention session lasts 4 hours). For each session, measurements will be taken at: 2 minutes pre-intervention, during intervention, immediately post-intervention, and 1 hour post-intervention.
Weight Gain in Preterm Neonates
Body weight will be measured in grams using a calibrated neonatal weighing scale, and weight change will be assessed.
Time frame: Baseline (Day 1), Day 5 (end of intervention), and Day 10 (follow-up).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 3 months is below that.
Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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