NCT01745510

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

Efficacy of Enteral Administration of the Docosahexaenoic Acid on Necrotizing Enterocolitis, Cytokines and Hospital Stay in Preterm Neonates

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 60 Minutes – 2 Weeks
• Healthy volunteers: Not accepted

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)

Detailed description

* Preterm neonates with birth weight less than 1500 g are in higher risk to develop NEC. * NEC is an inflammatory condition that: 1. Is the medical urgency most frequent of gastrointestinal tube that requires neonatal intensive care 2. may perforate infant´s bowel requiring surgery from 20% to 60% of the cases 3. may cause infant's death in 20% to 42% of the cases. 4. has no adequate treatment worldwide, therefore prevention is needed * DHA by enteral feeding has been administrated by our research group to attenuate inflammatory response in septic and surgical neonates. * Our results showed: 1. lower Interleukin(IL)-1 beta in septic neonates, but in surgical neonates, they also showed less IL-6 and anti-inflammatory cytokines IL-10 and IL-1ra, after adjusting by confounders 2. increased weight, length and fat mass gain in septic neonates 3. decreased organic failures in surgical neonates, and 4. lower stay at neonatal intensive care in surgical neonates 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

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Docosahexaenoic acid (DHA)	Docosahexaenoic acid from algae source
DIETARY_SUPPLEMENT	Placebo	Placebo was designed to mimic the color and consistence of the oil that contains DHA

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2012-12-10
• Last updated: 2021-03-24

Locations

1 site across 1 country: Mexico