Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docosahexaenoic acid | Dietary Supplement | Docosahexaenoic acid is a dietary supplement derived from algae. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of ROP | The study will determine the severity of retinopathy of prematurity as ordinal variable with frequencies, according to the following classification:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mariela Bernabe-Garcia, PhD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social | Mexico City | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16750345 | Background | 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. | |
| 22079797 | Background | Lopez-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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
Not provided
Not provided
Not provided
| sunflower oil | Dietary Supplement | Sunflower similar to the excipient used in experimental group |
|
| 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 |
| 27394149 | Background | Bernabe-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. |
| 27806350 | Background | Bernabe-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. |
| 30614004 | Result | Bernabe-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. |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |