Retinopathy of PrematurityNCT04883931
Mother Milk as a Eye Drop & Premature Retinopathy
A study testing Normal Saline and Breast milk in people with Retinopathy of Prematurity, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Normal Saline and Breast milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2021to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.
Who cannot join
- Infant death before first examination for ROP
- parents who want to leave from the study
- Contraindications for breast milk use (Active HIV infection, Active tuberculosis, CMV infection)
- Inborn error of metabolism like galactosemia.
- Congenital eye development disorders like agenesis, or situations that do not allow retina examination.
- other lethal congenital molformations
- congenital infections that affect the retina like TORCH infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.
The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.
Read the detailed description
Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the neonatal intensive care unit (NICU). The study will be carried out at Baskent University and it is planned that 70 participants will be included in the study.
Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of ROP, secondary outcome is severe ROP (laser requiring ROP).
- Conditions
- Retinopathy of Prematurity
- Being tested
- Normal Saline, Breast milk
- Keywords
- Breast milk, Retinopathy of Prematurity
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
0.5 ml 0.9% normal saline will drop on both eyes twice in a day.
Breast milkBiological
0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | With in 48-72 hour after birth, infants will receive 0.5 ml breast milk for own mother as a eye drop twice in a day until the discharge or need for laser coagulation. Fresh milk was used as eye drop ( not exceed 6 hours after milking). Receives: Biological: Breast milk |
| Placebo group | Placebo comparator | With in 48-72 hour after birth, infants will receive 0.5 ml 0.9% normal saline as a eye drop twice in a day until the discharge or need for laser coagulation. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinopathy of Prematurity
Number of participants with any stage of ROP
Measured: by 55 weeks post menstrual age
Secondary outcomes (1)
Retinopathy of Prematurity
Number of participants with laser requiring - severe ROP
Measured: by 55 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start6 May 2021
- Primary completion30 Nov 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Porspective Randomized Placebo Controlled Trail
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Konya City Hospital, Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics
- Responsible party
- Principal investigator, Musa Silahli, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883931
- Sponsor's protocol ID
- KA21/65
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Breast Milk as a Topical Ophthalmic Drop on Retinopathy of Prematurity. Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT04883931
- Acronym / sponsor ID
- KA21/65
- Conditions
- Retinopathy of Prematurity
- Keywords
- Breast milk, Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Konya City Hospital, Konya Dr. Ali Kemal Belviranli Hospital for Obstetrics and Pediatrics
- Study start
- 6 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.
Detailed description
Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the neonatal intensive care unit (NICU). The study will be carried out at Baskent University and it is planned that 70 participants will be included in the study.
Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of ROP, secondary outcome is severe ROP (laser requiring ROP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Porspective Randomized Placebo Controlled Trail
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Breast milkWith in 48-72 hour after birth, infants will receive 0.5 ml breast milk for own mother as a eye drop twice in a day until the discharge or need for laser coagulation. Fresh milk was used as eye drop ( not exceed 6 hours after milking). |
| Placebo group | Placebo comparator | Drug: Normal SalineWith in 48-72 hour after birth, infants will receive 0.5 ml 0.9% normal saline as a eye drop twice in a day until the discharge or need for laser coagulation. |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.
Key exclusion criteria (7 listed)
- Infant death before first examination for ROP
- parents who want to leave from the study
- Contraindications for breast milk use (Active HIV infection, Active tuberculosis, CMV infection)
- Inborn error of metabolism like galactosemia.
- Congenital eye development disorders like agenesis, or situations that do not allow retina examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline0.5 ml 0.9% normal saline will drop on both eyes twice in a day. | Drug | Placebo group |
| Breast milk0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day | Biological | Intervention group |
Primary outcome
Retinopathy of Prematurity
Time frame: by 55 weeks post menstrual age
Number of participants with any stage of ROP
1 secondary outcome
Retinopathy of Prematurity
Time frame: by 55 weeks post menstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline and Breast milk in people with Retinopathy of Prematurity, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinopathy of Prematurity (time frame: by 55 weeks post menstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.