Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams
- Registration Number
- NCT01536483
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Clinical management of very low birth weight newborns (VLBW \<1250g) consists in several challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a major cause of morbidity due to
1. the immaturity of GI functions (prolonged ileus, bacterial overgrowth and translocation),
2. the complication of GI tract immaturity: intestinal perforation and enterocolitis necrotizing)
3. the need of a prolonged parenteral nutrition and its complications (central venous catheter infections, sepsis, electrolyte disturbances) but without generate a high proof level on this targeted population (\<1250g).
The GI functions are progressively acquired during development and are largely sensitive to the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate increases gradually after birth. The beneficial effects of butyrate are related to its properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and upon the enteric nervous system (network of neurons and glial cells) that regulate GI functions and in particular colonic motility.
To date, there is no clinical consensus to manage digestive disorders of VLBW. Several clinical studies have assessed the effects of prokinetic drugs, dietary supplements (probiotics, prebiotics) but without generate a high proof level on this targeted population. In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g.
The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen (in particular the flora).
Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic mechanisms.
Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design.
The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams, by facilitating the development of colic motility and clinical nutrition tolerance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 61
- Any preterm infant with a birth weight less than or equal to 1250 grams admitted in the neonatal intensive care unit of Nantes Hospital
- Inborn or outborn
- No signs of gastrointestinal perforation or ECUN
- Absence of severe congenital disease
- Written informed consent of parental authority.
- Newborn with birth weight greater than 1250 grams,
- Gestational age > 30 AG
- Digestive pathology diagnosed prior PND5: perforation, necrotizing enterocolitis, malformations
- Severe congenital pathology inconsistent with clinical assessment.
- Parental Refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Butyrate Butyrate enemas New born with a birth weight \<1000g: Seven enemas of butyrate will be performed every 2 days from PND5 New born with a birth weight \>1000g: Seven enemas of butyrate will be performed every day from PND5
- Primary Outcome Measures
Name Time Method Efficacy of colonic butyrate enemas in digestive maturation of preterms participants will be followed for the duration of hospital stay, an expected average of 5 weeks The primary outcome of NEOTRANS study consists in the evaluation of the effects of colonic butyrate enemas upon the digestive maturation of preterms.
This endpoint is based on a clinical criteria that is the delay of weaning of the parenteral nutrition support. An increase of 25% (50 vs 75%) will be considered clinically significant.
Parenteral nutrition weaning is defined as the day where enteral caloric intake reach 80% of total calories.
- Secondary Outcome Measures
Name Time Method Gastrointestinal complications frequency participants will be followed for the duration of hospital stay, an expected average of 5 weeks Nosocomial infections frequency participants will be followed for the duration of hospital stay, an expected average of 5 weeks Iatrogenic effect participants will be followed for the duration of hospital stay, an expected average of 5 weeks whole gut transit time (red carmine test) participants will be followed for the duration of hospital stay, an expected average of 5 weeks Growth participants will be followed for the duration of hospital stay, an expected average of 5 weeks Comparaison between 2 arms of height, weight and head circumference
Invasive ventilation support participants will be followed for the duration of hospital stay, an expected average of 5 weeks Bronchopulmonary dysplasia incidence participants will be followed for the duration of hospital stay, an expected average of 5 weeks Neuromotor development 2 years ASQ questionnaire
Hospitalization duration participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Trial Locations
- Locations (1)
Nantes
🇫🇷Nantes, France