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The comparison of the effect of NIPPV and nCPAP on Brain Tissue Oxygen content in Preterm Neonates Weighing less than 1500 gr with Respiratory Distress Syndrome

The comparison of the effect of NIPPV and nCPAP on Brain Tissue Regional Oximetry in Preterm Neonates Weighing less than 1500 gr with RDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015123110430N7
Enrollment
32
Registered
2016-05-10
Start date
2015-05-22
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

studying the brain tissue oxymetry. Intraventricular (nontraumatic) haemorrhage, grade 3, of fetus and newborn

Interventions

Intervention 1: Control Group: In this group, neonates are treated with nCPAP for two hours with two-hour intervals. Intervention 2: Intervention Group: In this group, neonates are treated with NIPPV
Treatment - Other
Control Group: In this group, neonates are treated with nCPAP for two hours with two-hour intervals
Intervention Group: In this group, neonates are treated with NIPPV for two hours with two-hour intervals

Sponsors

Isfahan University of Medical Sciences-Vice chancellery of Research and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Days to 14 Days

Inclusion criteria

Inclusion criteria: Inclusion Criteria: preterm infants weighing less than 1500 gr who had been put under nCPAP respiratory support within 72 hours from birth due to RDS, and also received their first surfactant administration during the first two hours; RDS symptoms such as tachypnea, intercostal retraction, nasal flaring, grunting, and radiography suggestive of RDS; Survanta administration to achieve FiO2=30% and CDP=5 cm H2O in order to maintain SpO2 in the range of 89-95% in the right hand; IF at 72 hours from birth, newborns were under nCPAP respiratory support, and if in order to maintain SpO2 in the range of 89-95% in the right hand, CDP was in the range of 4 to 6 cm H2O, with FiO2 at 30% to 40%. EXCLUSION CRITERIA: Prenatal Asphyxia (5 min Apgar between 0 to 3, umbilical cord pH less than 7, and umbilical cord Bicarbonate less than 12mEq/L), and congenital disorders; newborns whose first dose of surfactant was administered later than 2 hours from birth; newborns who did not receive surfactant; newborns whose echocardigraphy revealed PDA symptoms; newborns who are under inotrope drugs administration; newborns whose cranial sonography suggested grade III to IV GM-IVH; newborns with air leak symptoms

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Brain tissue oxygenation. Timepoint: third day, seventh day, fourteenth day. Method of measurement: Near Infrared Spectroscopy.

Secondary

MeasureTime frame
Intraventicular hemorrhage. Timepoint: daily. Method of measurement: transcranial sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Sadeghnia

Isfahan University of Medical Sciences

asadeghnia@gmail.com+98 31 3335 1777

Outcome results

None listed

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