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" the Effect of the White noise on Behavioral Responses of Premature Infants" "the Effect Sound reduction on Behavioral Responses of Premature Infants "

Comparison the Effect of the White noise and Sound reduction on Behavioral Responses of Premature Infants under Non-invasive Ventilation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230709058729N1
Enrollment
32
Registered
2023-07-13
Start date
2023-07-22
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

behavioral responses of premature infants.

Interventions

Intervention 1: Intervention group: This study is a randomized clinical trial with cross-sectional design. The cross design used in this study is standard cross design 2x2 BA/AB). 32 preterm infants i

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Days to 36 Days

Inclusion criteria

Inclusion criteria: Parental Consent for Infant Participation in Research The baby's age ranges from 28 to 36 weeks and 6 days (based on LMP or ultrasound) Be under non-invasive ventilation and have not been at most 24 hours since the onset of non-invasive ventilation No invasive action was taken on the infant 2 hours before entering the study. Normality of OAE test No Counter-Indication to Change Positions Lack of drug use in the mother during pregnancy and after childbirth Not taking medications that affect the baby's sleep-wake cycle, such as theophylline, phenobarbital Lack of sedatives such as midazolam and fentanyl Absence of congenital abnormalities such as meningocele and meningomyelocele, meningitis, seizures, encephalopathy, congenital anomalies, asphyxia, intracranial hemorrhage greater than first-degree, sepsis, heart disease, metabolic and anemia. The baby is not SGA or IUGR. Having an Apgar score of 5 minutes above 6 Surgery on the baby after birth.

Exclusion criteria

Exclusion criteria: Poor baby (loss of consciousness, spo2 drop and change of vital signs from normal range) Dissatisfaction of the parent of the guardian to the continuation of the infant's participation in the research Infant death during the study Infant Transfer Need for invasive procedures during intervention Prescription of sedative drugs during intervention Developing neurological disorders such as seizures, grade 3 and 4 ventricular bleeding, sepsis Need for surgery Severe medical conditions that require the use of treatments such as sedatives, muscle relaxants, and analgesic medications Performing LP in baby Inappropriate medical condition, such as an unstable clinical condition Need for surgery

Design outcomes

Primary

MeasureTime frame
Behavioral response score of premature infant. Timepoint: Behavioral response score of preterm infant 2 minutes before, during and 2 minutes after intervention. Method of measurement: Infant Behavioral Reactions Registration Form Using Anderson Behavioral Response Scoring System (ABSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdieh Mohseni kakhki

Mashhad University of Medical Sciences

mohsenikm4012@mums.ac.ir+98 51 3859 1511

Outcome results

None listed

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