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Trial record 6 of 121 for:    Open Studies | "Birth Weight"

Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1000 Grams (NEOTRANS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01536483
First received: February 16, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

Clinical management of very low birth weight newborns (VLBW <1000g) 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 (<1000g).

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 1000 grams, by facilitating the development of colic motility and clinical nutrition tolerance.


Condition Intervention Phase
Very Low Birth Weight Preterms
Drug: Butyrate enemas
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1000 Grams. Clinical Trial Prospective, Monocentric, Randomized in Double-blinded.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Efficacy of colonic butyrate enemas in digestive maturation of preterms [ Designated as safety issue: No ]

    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:
  • Gastrointestinal complications frequency [ Designated as safety issue: No ]
  • Nosocomial infections frequency [ Designated as safety issue: No ]
  • Iatrogenic effect [ Designated as safety issue: No ]
  • whole gut transit time (red carmine test) [ Designated as safety issue: No ]
  • Growth [ Designated as safety issue: No ]
    Comparaison between 2 arms of height, weight and head circumference

  • Invasive ventilation support [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia incidence [ Designated as safety issue: No ]
  • Hospitalization duration [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: February 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Butyrate
Seven enemas of butyrate will be performed every 2 days from PND5
Drug: Butyrate enemas

Seven enemas will be performed every 2 days from PND5

  • Possibility to delay from 24 to 48 hours the procedure in case of clinical poor tolerance(maximum two enemas postponed and delayed at PND12 and PND13)
  • The study remains blinded for the investigation team through the intervention of a clinical research nurse
  • According to the procedure previously described by Nakaoka et al. (2009), a lubricated Foley catheter Ch 6 will be introduced into the rectum, the balloon will be inflated with 1 ml water for injections. Butyrate solution will be placed in a bag placed 50 cm above the child. Therefore, treatment administration will be performed at a controlled pressure of 50 cm H2O without any manual intervention
  • Installation time and retention is setted at 15 minutes
  • Treatment units will be directly placed in the incubator 30 min before the procedure to warm the enema to +36°C
  • Per-treatment clinical monitoring of the tolerance will be performed by a neonatologist
No Intervention: Therapeutic Abstention
The protocol will pretend enema: instillation in the diaper the product under consideration, to make the two indistinguishable processes (time, odor, wicking diaper ...)

  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any preterm infant with a birth weight less than or equal to 1000 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 1000 grams,
  • Gestational age > 30 AG
  • Digestive pathology diagnosed prior PND5: perforation, necrotizing enterocolitis, malformations
  • Severe congenital pathology inconsistent with clinical assessment.
  • Parental Refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536483

Contacts
Contact: Cyril FLAMANT, PhD +33 2 40 08 76 79 cyril.flamant@chu-nantes.fr

Locations
France
Nantes Recruiting
Nantes, France
Contact: Cyril FLAMANT, PhD    +33 2 40 08 76 79    cyril.flamant@chu-nantes.fr   
Principal Investigator: Cyril FLAMANT, PhD         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01536483     History of Changes
Other Study ID Numbers: 10/4-H
Study First Received: February 16, 2012
Last Updated: September 25, 2014
Health Authority: France : Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by Nantes University Hospital:
Butyrate
Preterms
Very Low Birth Weight (<1000g)
Rectocolonic enemas
Digestive maturation
Parenteral nutrition weaning
ECUN
Whole gut transit time

Additional relevant MeSH terms:
Birth Weight
Body Weight
Digestive System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014