Risk factors in retinopathy of prematurity

Risk predictors for the development of retinopathy of prematurity in very low birth weight neonates

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15382580

Enrollment

108

Registered

2016-07-12

Start date

2008-11-14

Completion date

Unknown

Last updated

2019-09-02

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

Conditions

Retinopathy of prematurity in very low birth weight neonates Eye Diseases

Interventions

The study aimed to evaluate risk factors for development of retinopathy of prematurity in preterm very low birth weight neonates. The study was a prospective, unmatched case control study conducted in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm babies weighting less than 1.5 kg and gestational age < 34 weeks.

Exclusion criteria

Exclusion criteria: Neonates with congenital anomalies

Design outcomes

Primary

Measure	Time frame
Occurrence of retinopathy of prematurity (ROP) in very low birth weight neonates (<1500g and <34 weeks of age) at four weeks of postnatal age. The screening was conducted by an experienced ophthalmologist	—

Secondary

Measure	Time frame
Assessment of a significant association between ROP and both maternal and neonatal risk predictors, via statistical analysis at 18 months from start of the study. Maternal risk predictors: type of delivery, maternal fever, Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, Premature Rupture of Membrane (PROM), antepartum hemorrhage, chorioamnionitis, multiple pregnancy, infertility treatment, urinary tract infections (UTI), polyhydramnios and oligohydramnios. Neonatal risk predictors: gestational age, birth weight, septicemia, apnoea, anemia, hypotension, need for inotropic support, type and duration of oxygen therapy, patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) and phototherapy.	—

Measure

Time frame

Assessment of a significant association between ROP and both maternal and neonatal risk predictors, via statistical analysis at 18 months from start of the study. Maternal risk predictors: type of delivery, maternal fever, Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, Premature Rupture of Membrane (PROM), antepartum hemorrhage, chorioamnionitis, multiple pregnancy, infertility treatment, urinary tract infections (UTI), polyhydramnios and oligohydramnios. Neonatal risk predictors: gestational age, birth weight, septicemia, apnoea, anemia, hypotension, need for inotropic support, type and duration of oxygen therapy, patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) and phototherapy.

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Countries

India

Outcome results

None listed

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