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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Coordinación de Investigación en Salud, Mexico
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01745510
First received: November 23, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose
  • 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)

Condition Intervention Phase
Necrotizing Enterocolitis
Dietary Supplement: Docosahexaenoic acid (DHA)
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Enteral Administration of the Docosahexaenoic Acid on Necrotizing Enterocolitis, Cytokines and Hospital Stay in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Necrotizing enterocolitis (NEC) [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10 [ Time Frame: At baseline, at day 3, and at day 14 ] [ Designated as safety issue: No ]
    Plasma cytokines will be determined before to the beginning of the enteral feeding (baseline), at day 3, and at day 14, of the beginning with enteral feeding. Cytokines will be measured by a multiplex kit in picograms/mL.

  • Hospital stay [ Time Frame: The duration of hospital stay, an expected average of 6 weeks ] [ Designated as safety issue: No ]
    Hospital stay includes intensive stay care and preterm service (where clinically stable babies are attended) until they are discharged from the hospital to home, in days.


Estimated Enrollment: 306
Study Start Date: October 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Dietary Supplement: Docosahexaenoic acid (DHA)
Docosahexaenoic acid from algae source
Other Name: n-3 Fatty Acids
Placebo Comparator: 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.

Dietary Supplement: Placebo
Placebo was designed to mimic the color and consistence of the oil that contains DHA
Other Name: Sunflower oil, Placebo for DHA intervention

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

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745510

Contacts
Contact: Mariela Bernabe-Garcia, PhD +52 55 56276944
Contact: Mardia Lopez-Alarcon, PhD + 52 55 56276944 marsau2@prodigy.net.mx

Locations
Mexico
Unit of Medical Research in Nutrition, Pediatric Hospital, IMSS Recruiting
Mexico City, Distrito Federal, Mexico, 06720
Contact: Mariela Bernabe-Garcia, PhD    +52 55 56276944    mariela_bernabe@yahoo.com   
Contact: Mardia Lopez-Alarcon, PhD    + 52 55 56276944    marsau2@prodigy.net.mx   
Sub-Investigator: Leovigildo Mateos, MSc         
Sub-Investigator: Mardia Lopez-Alarcon, PhD         
Principal Investigator: Mariela Bernabe-Garcia, PhD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Mariela Bernabe-Garcia, PhD Instituto Mexicano del Seguro Social
  More Information

Publications:
Responsible Party: Mariela Bernabe García, Principal investigator, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01745510     History of Changes
Other Study ID Numbers: DHA-ECN, DHA, ECN and Preterm
Study First Received: November 23, 2012
Last Updated: July 21, 2014
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by Coordinación de Investigación en Salud, Mexico:
docosahexaenoic acid
n-3 fatty acids
necrotizing enterocolitis
preterm infants

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 20, 2014