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Prevention of blindness in preterm infants

Can prophylactic propranolol prevent Retinopathy of Prematurity in premature infants less than 32 weeks: A Randomized Controlled Trial. - PREROP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/11/004131
Enrollment
52
Registered
2013-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Prevention of Retinopathy of Prematurity

Interventions

Intervention1: Propranolol: Preparation of Propranolol dose: Propranolol (10 mg tablet) will be dissolved in 10 ml of sterile water.The final solution will have concentration of 1mg/ml of propranolol.
the final solution will have concentration of 1mg/ml of calcium carbonate. This placebo will look similar to Propranolol solutions 0.5mg/kg/dose by infant feeding tube or per oral or orally, every 12

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infants with gestation age between 26 to 32 weeks admitted in NICU who are less than 1 week old

Exclusion criteria

Exclusion criteria: Recurrent episodes of bradycardia (heart rate less than 90 bpm) Atrio-ventricular blocks (second or third degree Hypotension (defined as mean BP less than gestational age of infant in first week of life) Refractory hypoglycemia (defined as blood glucose values less than 45 mg/dl despite interventions)

Design outcomes

Primary

MeasureTime frame
1.ROP all grades 2.ROP that needs treatment with laser and or anti VEGF Timepoint: 70 days Post natal age

Secondary

MeasureTime frame
To evaluate complications of Propranolol administration in preterm newborns 1.Recurrent bradycardia 2.Hypotension 3.Recurrent Hypoglycemia Timepoint: 70 days PNA

Countries

India

Contacts

Public ContactDr Kishore Pratap Sanghvi

Jaslok Hospital and Research Centre

dr.umesh.s@gmail.com9167149333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 6, 2026