Necrotizing Enterocolitis
Conditions
Keywords
docosahexaenoic acid, n-3 fatty acids, necrotizing enterocolitis, preterm infants
Brief 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)
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
Interventions
DIETARY_SUPPLEMENTDocosahexaenoic acid (DHA)
Docosahexaenoic acid from algae source
DIETARY_SUPPLEMENTPlacebo
Placebo was designed to mimic the color and consistence of the oil that contains DHA
Sponsors
National Council of Science and Technology, Mexico
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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
Intervention model description
The intervention was the docosahexaenoic acid, a nutraceutical derived from the omega 3 fatty acids.
Eligibility
Sex/Gender
ALL
Age
60 Minutes to 2 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing enterocolitis (NEC) | Patients will be followed for the duration of hospital stay, an expected average of 6 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay | The duration of hospital stay, an expected average of 6 weeks | 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. |
| Growth velocity in weight | Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks | Gain of weight in g/kd/day, measured with an electronic scale every week until hospital discharge or 40 weeks of corrected gestational age |
| Growth velocity in length and head circumference | Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks | 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. |
| Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10 | At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria | 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. |
| Enteral tolerance | During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks | 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. |
| Enteral intolerance | During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks | 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. |
| Growth velocity in skin folds | Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks | 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. |
Countries
Mexico
Outcome results
None listed