Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

Official title:

Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683317
• Other study ID #: R-2015-785-051
• Status: Completed
• Phase: N/A
• Start date: February 22, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: July 2020
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

• Birth weight < 1500 g

• Plan to feed by enteral way at a short term

• Written informed consent, signed by both parents.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Dietary Supplement:
• docosahexaenoic acid
Docosahexaenoic acid is a dietary supplement derived from algae.
• sunflower oil
Sunflower similar to the excipient used in experimental group

Locations

Country	Name	City	State
Mexico	Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Bernabe-Garcia M, López-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodríguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muñiz O. Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery. Ann Nutr Metab. 2016;69(2):150-160. Epub 2016 Nov 2. — View Citation

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. — View Citation

Bernabe-García M, Villegas-Silva R, Villavicencio-Torres A, Calder PC, Rodríguez-Cruz M, Maldonado-Hernández J, Macías-Loaiza D, López-Alarcón M, Inda-Icaza P, Cruz-Reynoso L. Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clini — View Citation

López-Alarcón M, Bernabe-García 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. Epub 2006 Jun 5. — View Citation

López-Alarcón M, Bernabe-García M, del Valle O, González-Moreno G, Martínez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1ß 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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	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