Analysis of Risk factors for Retinopathy of Prematurity in AGA vs SGA Preterm infants

Not Applicable

Completed

• Conditions: Health Condition 1: H351- Retinopathy of prematurity

• Registration Number: CTRI/2020/04/024682
• Lead Sponsor: Dr Arya Sandesh Wagle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

All babies with gestational age (GA) at birth of �36 weeks and a BW of �2000 g or neonates born with 36 weeks gestation or birth weight above 2000 g who are at risk of developing ROP shall be included:

ANTENATAL: Use of Antenatal steroids, Multiple gestation (monochorionic vs dichorionic twins), Antenatal Neuroprotection (use of Magnesium Sulphate), Chorioamnionitis leading to preterm birth, use of ART (assisted reproductive technology) for conception

NATAL: Resuscitation at birth, Poor APGAR score, Intraventricular Haemorrhage, Low birth weight, location of birth (hospital birth or home birth)

POSTNATAL: Poor weight gain velocity in the early postnatal period, use of pulmonary surfactant for RDS (respiratory distress syndrome), exposure to Oxygen therapy, Packed RBC (red blood cell) transfusion, use of Erythropoietin, PDA (patent ductus arteriosus), NEC (necrotising enterocolitis), recurrent Apnoea, Postnatal supplementation with PPN (partial parenteral nutrition), Culture proven Sepsis, Early postnatal hyperglycaemia

Exclusion Criteria

Babies with incomplete hospital documentation of pre and perinatal comorbidities will be excluded

Babies with incomplete data on BW or GA will also be excluded

Babies who died before complete resolution of ROP or did not attend the outpatient clinic for follow-up examinations will be excluded from the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis and comparison of the risk factors and severity of ROP with gestational categorization (AGA versus SGA)Timepoint: assessment of the outcome shall be carried out at the end of the study period

Secondary Outcome Measures

Name	Time	Method
Analysis and comparison of the risk factors and severity of ROP as AGA versus SGATimepoint: 1 year