Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams

NCT01536483 | Terminated Phase 2

• 1 other identifier: BRD/10/04-H
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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. 1.the immaturity of GI functions (prolonged ileus, bacterial overgrowth and translocation),
2. 2.the complication of GI tract immaturity: intestinal perforation and enterocolitis necrotizing)
3. 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).

Conditions

Very Low Birth Weight Preterms

Keywords

Butyrate; Preterms; Very Low Birth Weight (<1250g); Rectocolonic enemas; Digestive maturation; Parenteral nutrition weaning; ECUN; Whole gut transit time

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

Study Arms (2)

Butyrate

EXPERIMENTAL

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

Drug: Butyrate enemas

Therapeutic Abstention

NO INTERVENTION

The protocol will pretend enema: instillation in the diaper the product under consideration, to make the two indistinguishable processes (time, odor, wicking diaper ...)

Interventions

Butyrate enemas DRUG

Seven enemas * 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

Butyrate

Eligibility Criteria

• Age: 5 Days - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes

Nantes, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

FR (1)