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Effect of Sildenafil on the Development of Retinopathy of Prematurity in Preterm Infants

Evaluation of the Inhibitory Effect of Phosphodisterase Inhibitors Type 5 on the Development of Retinopathy of Prematurity in Preterm Infants

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015102314215N3
Enrollment
100
Registered
2016-02-17
Start date
2015-03-01
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

Vision Disorder. Retinopathy of prematurity Retrolental fibroplasia

Interventions

Intervention 1: In intervention group NCPAP therapy with 4-6 cm H2o begin as soon as possible in included cases. Infants who require Fio2= 40% to maintain o2 saturation= 90% will be intubated and trea
Treatment - Drugs
In intervention group NCPAP therapy with 4-6 cm H2o begin as soon as possible in included cases. Infants who require Fio2= 40% to maintain o2 saturation= 90% will be intubated and treated with intratr
In control group NCPAP therapy with 4-6 cm H2o begin as soon as possible in included cases. Infants who require Fio2= 40% to maintain o2 saturation= 90% will be intubated and treated with intratrachea

Sponsors

Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: newborns with gestational age less than 32 weeks; need to oxygen therapy. Exclusion criteria: blood sugar= 150mg% more than 7 days; metabolic acidosis (pH< 7.2) more than 24h; blood transfusion greater than 10ml/kg in first 4 weeks of life; sepsis with fungi.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Retinopathy stage 1. Timepoint: at 32 postconceptual age till 45 weeks postconceptual age. Method of measurement: Retinoscopy.

Secondary

MeasureTime frame
Stage2-5 retinopathy. Timepoint: at 32 till 45 weeks postconceptual age. Method of measurement: Retinoscopy.;The period of NCPAP therapy. Timepoint: Hour. Method of measurement: Use of NCPAP.;Period of Mechanical Ventilation therapy. Timepoint: Hour. Method of measurement: Use of ventilator.;Period of oxygen therapy. Timepoint: Hour. Method of measurement: Use of oxygen.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Dehdashtian

Ahvaz Jundishapur University of Medical Sciences

dehdashtian@ajums.ac.ir; m.dehdashtian@gmail.com+98 61 3338 9669

Outcome results

None listed

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