Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01745510
Other study ID # DHA-ECN
Secondary ID DHA, ECN and Pre
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 2012
Est. completion date October 2017

Study information

Verified date March 2021
Source Coordinación de Investigación en Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. - if NEC is prevented, this study will measure whether hospital stay is also reduced in neonates who receive Docosahexaenoic acid (DHA)


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


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Weeks
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Docosahexaenoic acid (DHA)
Docosahexaenoic acid from algae source
Placebo
Placebo was designed to mimic the color and consistence of the oil that contains DHA

Locations

Country Name City State
Mexico Unit of Medical Research in Nutrition, Pediatric Hospital, IMSS Mexico City Distrito Federal

Sponsors (2)

Lead Sponsor Collaborator
Coordinación de Investigación en Salud, Mexico National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Bernabe-García M, Calder PC, Villegas-Silva R, Rodríguez-Cruz M, Chávez-Sánchez L, Cruz-Reynoso L, Mateos-Sánchez L, Lara-Flores G, Aguilera-Joaquín AR, Sánchez-García L. Efficacy of Docosahexaenoic Acid for the Prevention of Necrotizing Enterocolitis in — View Citation

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. — View Citation

López-Alarcón M, Bernabe-García 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. Epub 2006 Jun 5. — View Citation

López-Alarcón M, Bernabe-García M, del Valle O, González-Moreno G, Martínez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1ß 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Patients will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary 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. At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria
Secondary 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. The duration of hospital stay, an expected average of 6 weeks
Secondary 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 Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks
Secondary 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. Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks
Secondary 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. Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks
Secondary 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. During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks
Secondary 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. During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05544097 - Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis N/A
Recruiting NCT03210831 - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Recruiting NCT02552706 - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis N/A
Completed NCT02400697 - Placental Transfusion Project for Preterm Infants N/A
Completed NCT01751477 - Infloran® for Prevention of Necrotizing Enterocolitis N/A
Terminated NCT01156480 - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Recruiting NCT01441739 - Intestinal Failure in Necrotising Enterocolitis N/A
Recruiting NCT03869827 - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting NCT04074824 - A Genome-Wide Association Study for Neonatal Diseases
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting NCT04541771 - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Phase 2
Not yet recruiting NCT03700957 - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT01735578 - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis N/A
Unknown status NCT01807858 - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants N/A
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1