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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT01745510
• Date of registration: 23/11/2012
• Prospective Registration: No
• Primary sponsor: Coordinación de Investigación en Salud, Mexico
• Public title: Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates
• Scientific title: Efficacy of Enteral Administration of the Docosahexaenoic Acid on Necrotizing Enterocolitis, Cytokines and Hospital Stay in Preterm Neonates
• Date of first enrolment: October 2012
• Target sample size: 225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01745510
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Mexico

Contacts

• Name: Mariela Bernabe-Garcia, PhD
• Affiliation: Instituto Mexicano del Seguro Social

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: N/A
Age maximum: 2 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Necrotizing Enterocolitis

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Docosahexaenoic acid (DHA)

Primary Outcome(s)

Necrotizing enterocolitis (NEC) [Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 6 weeks]

Secondary Outcome(s)

Growth velocity in weight [Time Frame: Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks]

Enteral tolerance [Time Frame: During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks]

Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10 [Time Frame: At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria]

Growth velocity in length and head circumference [Time Frame: Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks]

Hospital stay [Time Frame: The duration of hospital stay, an expected average of 6 weeks]

Enteral intolerance [Time Frame: During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks]

Growth velocity in skin folds [Time Frame: Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks]

Secondary ID(s)

DHA-ECN

DHA, ECN and Preterm

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Council of Science and Technology, Mexico