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

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 2; Phase 1

Conditions: Necrotizing Enterocolitis

Treatments: Dietary Supplement: Docosahexaenoic acid (DHA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01745510

DHA, ECN and Preterm (Other Grant/Funding Number)

DHA-ECN

Details and patient eligibility

About

• 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)

Full 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

Enrollment: 225 patients

Sex: All

Ages: 60 minutes to 2 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 2 patient groups, including a placebo group

DHA Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Docosahexaenoic acid (DHA)

Control Group (Placebo)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo