Retinopathy of PrematurityNCT02683317
Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity
A study testing docosahexaenoic acid and sunflower oil in people with Retinopathy of Prematurity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants. Read more about this study
- Who is it for?
- Ages 60 minutes to 2 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- docosahexaenoic acid and sunflower oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMexico
- Study dates
- 22 Feb 2016to 31 Oct 2017
- 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 60 minutes to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight < 1500 g
- Plan to feed by enteral way at a short term
- Written informed consent, signed by both parents.
Who cannot join
- Congenital malformations that avoid enteral feeding
- immunosuppressor diseases
- Need for major surgery
- Persistent bleeding at any level
- Mother taking n-3 supplements and planning to breastfed
- Parents who decline the authorization for participating in the study
- Early discharge to other hospital outside the metropolitan area
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06720
About this study
Official title: Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.
Read the detailed description
Preterm neonates who start receiving enteral feeding will receive the intervention with docosahexaenoic acid (DHA) since the first day and throughout 14 days, one dose per day.
The opthalmic evaluation will be done after 4-5 weeks after birth and followed until 42-45 corrected gestational age.
- Conditions
- Retinopathy of Prematurity
- Being tested
- docosahexaenoic acid, sunflower oil
- Keywords
- DHA, 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.
docosahexaenoic acidDietary supplement
Also called n-3 long chain polyunsaturated fatty acid
Docosahexaenoic acid is a dietary supplement derived from algae.
sunflower oilDietary supplement
Sunflower similar to the excipient used in experimental group
| Study group | Role | What they receive |
|---|---|---|
| DHA group | Experimental | Experimental group will receive 75 mg of docosahexaenoic acid per kilo of baseline weight in one dose per day, administered by enteral feeding throughout 14 days. Receives: Dietary Supplement: docosahexaenoic acid |
| Control group | Sham comparator | Control group will receive sunflower oil, the excipient of the DHA in our intervention.
They will receive it once a day, administered by enteral feeding throughout 14 days. Receives: Dietary Supplement: sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of retinopathy of prematurity (ROP)
The medical screening to determine the presence ROP will include the exhaustive search of injury on the zone, stage and the presence of plus disease in retina of the preterm infants. The measure unit is frequency of ROP (presence =1 or absence=0) registering the corrected gestational age of the first identification.
Measured: ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.
Secondary outcomes (1)
Severity of ROP
The study will determine the severity of retinopathy of prematurity as ordinal variable with frequencies, according to the following classification:
- ROP stage 1 or threshold needs treatment:
- ROP in Zone I any stage if it is associate to presence of Plus.
- ROP stage 1 in Zone I + Plus disease
- ROP stage 2 in Zone I + Plus disease
- ROP stage 3 in Zone I + Plus disease
- ROP in Zone I Stage 3 with or without Plus disease.
- ROP in Zone II Stage 2 or 3 + Plus disease.
- ROP Stage 2 or pre-threshold, require close monitoring:
- ROP in Zone I, Stage 1 or 2 without Plus
- ROP in Zone II, Stage 3 without Plus
- ROP in zone II or III, Stage 1 or 2 without Plus, require periodic monitoring.
- ROP in remission
- Without retinopathy
Measured: ROP will be evaluated as changes in each retina's eye from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start22 Feb 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico
- Investigators
- Mariela Bernabe-Garcia, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683317
- Sponsor's protocol ID
- R-2015-785-051
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lopez-Alarcon M, Bernabe-Garcia M, Del Prado M, Rivera D, Ruiz G, Maldonado J, Villegas R. Docosahexaenoic acid administered in the acute phase protects the nutritional status of septic neonates. Nutrition. 2006 Jul-Aug;22(7-8):731-7. doi: 10.1016/j.nut.2006.04.002. Epub 2006 Jun 5.
PubMed 16750345Lopez-Alarcon M, Bernabe-Garcia M, del Valle O, Gonzalez-Moreno G, Martinez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1beta response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. Epub 2011 Nov 12.
PubMed 22079797Bernabe-Garcia M, Lopez-Alarcon M, Villegas-Silva R, Mancilla-Ramirez J, Rodriguez-Cruz M, Maldonado-Hernandez J, Chavez-Rueda KA, Blanco-Favela F, Espinoza-Garcia L, Lagunes-Salazar S. Beneficial Effects of Enteral Docosahexaenoic Acid on the Markers of Inflammation and Clinical Outcomes of Neonates Undergoing Cardiovascular Surgery: An Intervention Study. Ann Nutr Metab. 2016;69(1):15-23. doi: 10.1159/000447498. Epub 2016 Jul 9.
PubMed 27394149Bernabe-Garcia M, Lopez-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodriguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muniz O. Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery. Ann Nutr Metab. 2016;69(2):150-160. doi: 10.1159/000452227. Epub 2016 Nov 2.
PubMed 27806350Bernabe-Garcia M, Villegas-Silva R, Villavicencio-Torres A, Calder PC, Rodriguez-Cruz M, Maldonado-Hernandez J, Macias-Loaiza D, Lopez-Alarcon M, Inda-Icaza P, Cruz-Reynoso L. Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial. JPEN J Parenter Enteral Nutr. 2019 Sep;43(7):874-882. doi: 10.1002/jpen.1497. Epub 2019 Jan 6.
PubMed 30614004
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT02683317
- Acronym / sponsor ID
- R-2015-785-051
- Conditions
- Retinopathy of Prematurity
- Keywords
- DHA, Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 17 Feb 2016 (estimated)
- 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 purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.
Detailed description
Preterm neonates who start receiving enteral feeding will receive the intervention with docosahexaenoic acid (DHA) since the first day and throughout 14 days, one dose per day.
The opthalmic evaluation will be done after 4-5 weeks after birth and followed until 42-45 corrected gestational age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
| Arm | Type | Receives |
|---|---|---|
| DHA group | Experimental | Dietary Supplement: docosahexaenoic acidExperimental group will receive 75 mg of docosahexaenoic acid per kilo of baseline weight in one dose per day, administered by enteral feeding throughout 14 days. |
| Control group | Sham comparator | Dietary Supplement: sunflower oilControl group will receive sunflower oil, the excipient of the DHA in our intervention. They will receive it once a day, administered by enteral feeding throughout 14 days. |
Who may qualify
- Ages
- 60 minutes to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight < 1500 g
- Plan to feed by enteral way at a short term
- Written informed consent, signed by both parents.
Key exclusion criteria (7 listed)
- Congenital malformations that avoid enteral feeding
- immunosuppressor diseases
- Need for major surgery
- Persistent bleeding at any level
- Mother taking n-3 supplements and planning to breastfed
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 |
|---|---|---|
| docosahexaenoic acidAlso: n-3 long chain polyunsaturated fatty acidDocosahexaenoic acid is a dietary supplement derived from algae. | Dietary supplement | DHA group |
| sunflower oilSunflower similar to the excipient used in experimental group | Dietary supplement | Control group |
Primary outcome
Presence of retinopathy of prematurity (ROP)
Time frame: ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.
The medical screening to determine the presence ROP will include the exhaustive search of injury on the zone, stage and the presence of plus disease in retina of the preterm infants. The measure unit is frequency of ROP (presence =1 or absence=0) registering the corrected gestational age of the first identification.
1 secondary outcome
Severity of ROP
Time frame: ROP will be evaluated as changes in each retina's eye from 4 to 5 weeks after birth throughout 42-45 of corrected gestational 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 17 Jul 2020.
- Background: PubMed 16750345Lopez-Alarcon M, Bernabe-Garcia M, Del Prado M, Rivera D, Ruiz G, Maldonado J, Villegas R. Docosahexaenoic acid administered in the acute phase protects the nutritional status of septic neonates. Nutrition. 2006 Jul-Aug;22(7-8):731-7. doi: 10.1016/j.nut.2006.04.002. Epub 2006 Jun 5.
- Background: PubMed 22079797Lopez-Alarcon M, Bernabe-Garcia M, del Valle O, Gonzalez-Moreno G, Martinez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1beta response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. Epub 2011 Nov 12.
- Background: PubMed 27394149Bernabe-Garcia M, Lopez-Alarcon M, Villegas-Silva R, Mancilla-Ramirez J, Rodriguez-Cruz M, Maldonado-Hernandez J, Chavez-Rueda KA, Blanco-Favela F, Espinoza-Garcia L, Lagunes-Salazar S. Beneficial Effects of Enteral Docosahexaenoic Acid on the Markers of Inflammation and Clinical Outcomes of Neonates Undergoing Cardiovascular Surgery: An Intervention Study. Ann Nutr Metab. 2016;69(1):15-23. doi: 10.1159/000447498. Epub 2016 Jul 9.
- Background: PubMed 27806350Bernabe-Garcia M, Lopez-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodriguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muniz O. Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery. Ann Nutr Metab. 2016;69(2):150-160. doi: 10.1159/000452227. Epub 2016 Nov 2.
- Results publication: PubMed 30614004Bernabe-Garcia M, Villegas-Silva R, Villavicencio-Torres A, Calder PC, Rodriguez-Cruz M, Maldonado-Hernandez J, Macias-Loaiza D, Lopez-Alarcon M, Inda-Icaza P, Cruz-Reynoso L. Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial. JPEN J Parenter Enteral Nutr. 2019 Sep;43(7):874-882. doi: 10.1002/jpen.1497. Epub 2019 Jan 6.
- 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.
Mariela Bernabe-Garcia, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing docosahexaenoic acid and sunflower oil in people with Retinopathy of Prematurity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 3 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 17 Jul 2020. 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 Mexico. 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?
Presence of retinopathy of prematurity (ROP) (time frame: ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683317, which also lists 5 linked publications.
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 17 Jul 2020.