Very Low Birth Weight Preterms Clinical Trial
— NEOTRANSOfficial title:
Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams. Clinical Trial Prospective, Monocentric, Randomized in Double-blinded.
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.
| Status | Terminated |
| Enrollment | 61 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 5 Days |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Nantes | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of colonic butyrate enemas in digestive maturation of preterms | 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. |
participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No |
| Secondary | Gastrointestinal complications frequency | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | Nosocomial infections frequency | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | Iatrogenic effect | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | whole gut transit time (red carmine test) | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | Growth | Comparaison between 2 arms of height, weight and head circumference | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No |
| Secondary | Invasive ventilation support | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | Bronchopulmonary dysplasia incidence | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | Hospitalization duration | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | No | |
| Secondary | Neuromotor development | ASQ questionnaire | 2 years | No |