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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-10-31

Brief Summary

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* 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)

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Detailed Description

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* 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

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Necrotizing Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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

Study Groups

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DHA Group

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

Group Type EXPERIMENTAL

Docosahexaenoic acid (DHA)

Intervention Type DIETARY_SUPPLEMENT

Docosahexaenoic acid from algae source

Control Group (Placebo)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Docosahexaenoic acid (DHA)

Docosahexaenoic acid from algae source

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3 Fatty Acids Sunflower oil, Placebo for DHA intervention

Eligibility Criteria

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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

Minimum Eligible Age

60 Minutes

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No