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Oxygen drops during eye injections in preterm babies: a hidden risk?

NCT ID NCT07701759

Knowledge-focused Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study looks at how often oxygen levels drop in premature infants when they receive an eye injection of ranibizumab for retinopathy of prematurity (ROP). Researchers reviewed records from 74 infants treated across multiple hospitals, tracking oxygen saturation during the procedure. The goal is to understand the frequency and severity of hypoxia, which has not been well studied in this setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ranibizumab
What this could lead to
If this study identifies how often and how severely oxygen levels drop during treatment, it could lead to better monitoring and safer procedures for premature infants with ROP.
What could go wrong
This is a small, retrospective observational study, so it can show patterns but cannot prove cause and effect. Results may not apply to all hospitals or treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A retrospective multicenter observational study was conducted at Ophthalmology Department, Qassim University Medical City involving premature infants who underwent intravitreal Ranibizumab injection for treatment-requiring ROP between July 2020 and June 2026. Demographic, maternal, perinatal, ophthalmic, and treatment-related data were collected registered and analyzed.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Premature infants with treatment-requiring ROP. * Treatment with intravitreal ranibizumab. * Complete procedural monitoring records, including continuous pulse oximetry. * Availability of follow-up data after treatment. Exclusion criteria Infants were excluded if they had: * Incomplete procedural or follow-up data. * Major congenital anomalies affecting cardiorespiratory function. * Bronchopulmonary dysplasia. * Intraventricular hemorrhage. * Patent ductus arteriosus. * Respiratory distress syndrome requiring surfactant therapy.

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Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinopathy of prematurity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • QUMC

    RECRUITING

    Buraidah, Saudi Arabia

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