Necrotizing Enterocolitis Clinical Trial
Official title:
Efficacy of Enteral Administration of the Docosahexaenoic Acid on Necrotizing Enterocolitis, Cytokines and Hospital Stay in Preterm Neonates
Verified date | March 2021 |
Source | Coordinación de Investigación en Salud, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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)
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Unit of Medical Research in Nutrition, Pediatric Hospital, IMSS | Mexico City | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico | National Council of Science and Technology, Mexico |
Mexico,
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
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 |
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