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| ID | Type | Description | Link |
|---|---|---|---|
| DHA, ECN and Preterm | Other Grant/Funding Number | CONACYT 161643 |
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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
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Preterm neonates with birth weight less than 1500 g are in higher risk to develop NEC.
NEC is an inflammatory condition that:
DHA by enteral feeding has been administrated by our research group to attenuate inflammatory response in septic and surgical neonates.
Our results showed:
DHA has not been used as unique intervention at a high but physiological dose; in addition, our previous results found an anti-inflammatory effect in neonates.Therefore, we expect that preterm infants may have a reduced bowel inflammatory response and lower NEC events and or severity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA Group | Experimental | DHA Group will receive 75 milligrams of docosahexaenoic acid (DHA) per kilogram of their baseline weight. They will receive one dose, administered by enteral feeding every 24 h during 14 days |
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| Control Group (Placebo) | Placebo Comparator | Control group will receive sunflower oil which is the excipient of the DHA in this study. They will receive one dose every 24 h during 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosahexaenoic acid (DHA) | Dietary Supplement | Docosahexaenoic acid from algae source |
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| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis (NEC) | Neonates will receive enteral DHA at beginning of their first enteral feeding and NEC will be diagnosed during hospital stay, measured as presence or absence, as well as severity of NEC by Bell's score. | Patients will be followed for the duration of hospital stay, an expected average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10 | Plasma cytokines will be determined before to the beginning of the enteral feeding (baseline) and if the infant develop confirmed or severe NEC. Cytokines will be measured by a multiplex kit in picograms/mL. | At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariela Bernabe-Garcia, PhD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Medical Research in Nutrition, Pediatric Hospital, IMSS | 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. |
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This project has secondary outcomes that have not been analyzed; therefore, in this moment we decided not to share our database.
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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The intervention was the docosahexaenoic acid, a nutraceutical derived from the omega 3 fatty acids.
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Intervention was blinded through assinging a code, printed and saved into opaque envelopes did it by a researcher who did not participate in the fieldwork.
Randomization was carried out through the Random Allocation Software v.1
| Placebo | Dietary Supplement | Placebo was designed to mimic the color and consistence of the oil that contains DHA |
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| Hospital stay | Hospital stay includes intensive stay care and preterm service (where clinically stable babies are attended) until they are discharged from the hospital to home, in days. | The duration of hospital stay, an expected average of 6 weeks |
| Growth velocity in weight | Gain of weight in g/kd/day, measured with an electronic scale every week until hospital discharge or 40 weeks of corrected gestational age | Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks |
| Growth velocity in length and head circumference | Gain of recumbent length and and head circumference in cm/week measured every 2 weeks until hospital discharge or 40 weeks of corrected gestational age. For measuring length we will use an infantometer and for head circumference we will use a glass fiber tape. | Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks |
| Growth velocity in skin folds | Gain of bicipital, tricipital, suprailiac and subscapular skin folds in mm/week measured every 2 weeks, until hospital discharge or 40 weeks of corrected gestational age. We will use a glass fiber tape to measure it. | Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks |
| Enteral tolerance | Registration of volume of the enteral intake every 24 h (ml/kg/day) until reach 150 ml/kg/day and being sustained or increased by enteral feeding with human milk or formula. | During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks |
| Enteral intolerance | Registration of number of patients with clinical signs of intolerance such as vomit, abnormal number of stool loss, abdominal distension, number of patients with medical indication to withdraw enteral feeding due clinical unstability and number of patients with use of medications related to enteral tolerance such as omeprazole, ranitidine, vitamins, iron, etc. | During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks |
| 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. |
| 33671220 | Result | Bernabe-Garcia M, Calder PC, Villegas-Silva R, Rodriguez-Cruz M, Chavez-Sanchez L, Cruz-Reynoso L, Mateos-Sanchez L, Lara-Flores G, Aguilera-Joaquin AR, Sanchez-Garcia L. Efficacy of Docosahexaenoic Acid for the Prevention of Necrotizing Enterocolitis in Preterm Infants: A Randomized Clinical Trial. Nutrients. 2021 Feb 17;13(2):648. doi: 10.3390/nu13020648. |
| D007410 |
| Intestinal Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |