Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates

NCT01745510 | Completed Phase 1 DMC

• 2 other identifiers: DHA-ECNDHA, ECN and Preterm
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

• The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm neonates \< 1500 g at birth who are starting enteral feeding.
• if NEC is prevented, this study will measure whether hospital stay is also reduced in neonates who receive Docosahexaenoic acid (DHA)

Conditions

Necrotizing Enterocolitis

Keywords

docosahexaenoic acid; n-3 fatty acids; necrotizing enterocolitis; preterm infants

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10

  At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria

• Hospital stay

  The duration of hospital stay, an expected average of 6 weeks

• Growth velocity in weight

  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

  Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks

• Growth velocity in skin folds

  Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks

Study Arms (2)

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

Dietary Supplement: Docosahexaenoic acid (DHA)

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.

Dietary Supplement: Placebo

Interventions

Docosahexaenoic acid (DHA) DIETARY_SUPPLEMENT

Docosahexaenoic acid from algae source

Also known as: n-3 Fatty Acids

DHA Group

Placebo DIETARY_SUPPLEMENT

Placebo was designed to mimic the color and consistence of the oil that contains DHA

Also known as: Sunflower oil, Placebo for DHA intervention

Control Group (Placebo)

Eligibility Criteria

• Age: 60 Minutes - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight lower than 1500 g
• Adequate weight for gestational age
• Clinically stable to begin enteral feeding
• Written informed consent by both parents plus the sign of two witnesses

You may not qualify if:

• Clinical and biochemical data of inflammatory response such as body core temperature altered, cardiac and respiratory frequency -low or high according to age-, leucocytosis or leucopenia, taking into account the thresholds reported by Goldstein in Pediatric Critical Care Medicine 2005 Vol 6 N°1.
• 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
• Persistent vomiting
• Receiving medication to avoid coagulation
• Gastrointestinal malformations

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Unit of Medical Research in Nutrition, Pediatric Hospital, IMSS

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (4)

• 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.

  PMID: 16750345 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.

  PMID: 22079797 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.

  PMID: 27394149 BACKGROUND

• 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.

  PMID: 33671220 RESULT

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3; Sunflower Oil

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Mariela Bernabe-Garcia, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The intervention was the docosahexaenoic acid, a nutraceutical derived from the omega 3 fatty acids.

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: December 10, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)