This study is currently not recruiting participants.

INS-3: A Phase 3 Randomized Double-Masked Placebo-Controlled Study of the Efficacy and Safety of myo-Inositol 5% Injection to Increase Survival without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants

Study of Inositol in Premature Babies for Eye and Lung Health

Not Recruiting
100 years or below
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to learn if giving premature babies Inositol can reduce the number of babies who get severe Retinopathy of Prematurity (ROP), and to learn if Inositol can help reduce bronchopulmonary dysplasia (BPD).

Detailed description of study

The purpose of this study is to learn if giving premature babies Inositol can reduce the number of babies who get severe Retinopathy of Prematurity (ROP), and to learn if Inositol can help reduce bronchopulmonary dysplasia (BPD).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: premature birth
  • Age: 100 years or below
  • Gender: All

This study investigates the use of Inositol in premature babies to see if it can reduce the number of cases of severe Retinopathy of Prematurity (ROP). Retinopathy of Prematurity is an eye disease that can occur in premature infants and may lead to vision problems.

The study also examines if Inositol can help lessen bronchopulmonary dysplasia (BPD), a chronic lung disease that affects newborns. Participants will receive either Inositol or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: The study is open to premature babies, specifically those at risk of developing severe Retinopathy of Prematurity or bronchopulmonary dysplasia. Eligible participants are premature infants born at less than 32 weeks of gestation.
  • Study details: Participants will receive either Inositol or a placebo, an inactive substance that resembles the investigational medication but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1405003939

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