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Necrotizing EnterocolitisPhase 1/2NCT01745510

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

A Phase 1/2 study testing Docosahexaenoic acid (DHA) in people with Necrotizing Enterocolitis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 minutes to 2 weeks
Conditions the study is for
Necrotizing Enterocolitis
What is being tested?
Docosahexaenoic acid (DHA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
1 siteMexico
Study dates
Oct 2012to Oct 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 minutes to 2 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

  • Unit of Medical Research in Nutrition, Pediatric Hospital, IMSS

    Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

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

  • 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)
Read the 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

Being tested
Docosahexaenoic acid (DHA), Placebo
Keywords
docosahexaenoic acid, n-3 fatty acids, necrotizing enterocolitis, preterm infants
Medical subject headings
Enterocolitis, Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docosahexaenoic acid (DHA)Dietary supplement

    Also called n-3 Fatty Acids

    Docosahexaenoic acid from algae source

  • PlaceboDietary supplement

    Also called Sunflower oil, Placebo for DHA intervention

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

Study groups in NCT01745510
Study groupRoleWhat they receive
DHA GroupExperimentalDHA 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
Receives: Dietary Supplement: Docosahexaenoic acid (DHA)
Control Group (Placebo)Placebo comparatorControl 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Necrotizing enterocolitis (NEC)

    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.

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary outcomes (7)

  1. Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10

    Plasma cytokines will be determined before to the beginning of the enteral feeding (baseline) and if the infant develop confirmed or severe NEC. Cytokines will be measured by a multiplex kit in picograms/mL.

    Measured: At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria

  2. Hospital stay

    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.

    Measured: The duration of hospital stay, an expected average of 6 weeks

  3. Growth velocity in weight

    Gain of weight in g/kd/day, measured with an electronic scale every week until hospital discharge or 40 weeks of corrected gestational age

    Measured: Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks

  4. Growth velocity in length and head circumference

    Gain of recumbent length and and head circumference in cm/week measured every 2 weeks until hospital discharge or 40 weeks of corrected gestational age. For measuring length we will use an infantometer and for head circumference we will use a glass fiber tape.

    Measured: Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks

  5. Growth velocity in skin folds

    Gain of bicipital, tricipital, suprailiac and subscapular skin folds in mm/week measured every 2 weeks, until hospital discharge or 40 weeks of corrected gestational age. We will use a glass fiber tape to measure it.

    Measured: Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks

  6. Enteral tolerance

    Registration of volume of the enteral intake every 24 h (ml/kg/day) until reach 150 ml/kg/day and being sustained or increased by enteral feeding with human milk or formula.

    Measured: During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks

  7. Enteral intolerance

    Registration of number of patients with clinical signs of intolerance such as vomit, abnormal number of stool loss, abdominal distension, number of patients with medical indication to withdraw enteral feeding due clinical unstability and number of patients with use of medications related to enteral tolerance such as omeprazole, ranitidine, vitamins, iron, etc.

    Measured: During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention was the docosahexaenoic acid, a nutraceutical derived from the omega 3 fatty acids.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01745510
Sponsor's protocol ID
DHA-ECN
Other IDs
DHA, ECN and Preterm
Status last verified
Mar 2021
First submitted
23 Nov 2012
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: This project has secondary outcomes that have not been analyzed; therefore, in this moment we decided not to share our database.

Publications

  • Lopez-Alarcon M, Bernabe-Garcia M, Del Prado M, Rivera D, Ruiz G, Maldonado J, Villegas R. Docosahexaenoic acid administered in the acute phase protects the nutritional status of septic neonates. Nutrition. 2006 Jul-Aug;22(7-8):731-7. doi: 10.1016/j.nut.2006.04.002. Epub 2006 Jun 5.

    PubMed 16750345

  • Lopez-Alarcon M, Bernabe-Garcia M, del Valle O, Gonzalez-Moreno G, Martinez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1beta response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. Epub 2011 Nov 12.

    PubMed 22079797

  • Bernabe-Garcia M, Lopez-Alarcon M, Villegas-Silva R, Mancilla-Ramirez J, Rodriguez-Cruz M, Maldonado-Hernandez J, Chavez-Rueda KA, Blanco-Favela F, Espinoza-Garcia L, Lagunes-Salazar S. Beneficial Effects of Enteral Docosahexaenoic Acid on the Markers of Inflammation and Clinical Outcomes of Neonates Undergoing Cardiovascular Surgery: An Intervention Study. Ann Nutr Metab. 2016;69(1):15-23. doi: 10.1159/000447498. Epub 2016 Jul 9.

    PubMed 27394149

  • Bernabe-Garcia M, Calder PC, Villegas-Silva R, Rodriguez-Cruz M, Chavez-Sanchez L, Cruz-Reynoso L, Mateos-Sanchez L, Lara-Flores G, Aguilera-Joaquin AR, Sanchez-Garcia L. Efficacy of Docosahexaenoic Acid for the Prevention of Necrotizing Enterocolitis in Preterm Infants: A Randomized Clinical Trial. Nutrients. 2021 Feb 17;13(2):648. doi: 10.3390/nu13020648.

    PubMed 33671220

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docosahexaenoic acid (DHA) in people with Necrotizing Enterocolitis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Necrotizing enterocolitis (NEC) (time frame: Patients will be followed for the duration of hospital stay, an expected average of 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01745510, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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