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Effect of bath on clinical outcomes in preterm infants: a randomized controlled trial

Effect of bath on clinical outcomes in preterm infants: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201306164617N7
Enrollment
100
Registered
2013-06-28
Start date
2013-09-01
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

Bath outcome in preterm infants.

Interventions

Intervention 1: Intervention infants, every three days, each time for 5 minutes, will be bathed in the bathtub by two helping researchers. In total during the study these infants will experience this
Intervention infants, every three days, each time for 5 minutes, will be bathed in the bathtub by two helping researchers. In total during the study these infants will experience this type of bath ju
Infants in the control group will receive only the routine skin care which is common in that unit

Sponsors

Deputy of research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age of infants 34-37 weeks of gestation; infant's age at study entry should be 72 hours after birth; no chromosomal abnormalities and congenital anomaly; 5-minute Apgar score of 7; Physiologic stability and no need to oxygen; not having any discharge or bleeding at the site of the umbilical cord; exclusive breast feeding; lack of feeding for at least half an hour before bath; not receiving drugs that affect the level of consciousness, like: phenobarbital; not having a brain hemorrhage, asphyxia, kernicterus, and diseases leading to loss of consciousness; having a baseline baby's body temperature that should be at 36.5 ° C and parent consent for participating of infant in the study. Exclusion criteria: occurrence of symptoms such as apnea and cyanosis, or have any ill during bathing; baby bathe in the intervention and control groups by staff without notice; washing any parts of baby's body in the intervention and control groups for any reason (including changing diapers, etc.); at least one hour before intervention; tendency of control infant's mother to bath her baby; the baby's mother's unwillingness to continue the study in the intervention group (giving the baby a bath); low frequency of infants' bathing in the intervention group during the study (less than two).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Changes of body temperature of preterm infants. Timepoint: On intervention days in 10 minutes before and 10 minutes after the bath. Method of measurement: Using a mercury thermometer.

Secondary

MeasureTime frame
O2 saturation of preterm infants. Timepoint: On intervention days in 10 minutes before and 10 minutes after the bath. Method of measurement: Using a novametrix pulse oximeter.;Heart rates of preterm infants. Timepoint: On intervention days in 10 minutes before and 10 minutes after the bath. Method of measurement: Using a novametrix pulse oximeter.;Weight gain preterm infant. Timepoint: Throughout the study period; daily. Method of measurement: Using a Seca Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmeneh Safaei

Tabriz University of Medical Sciences

b.a.safaee1365@gmail.com+98 41 1380 3738

Outcome results

None listed

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