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The second intermediary analysis showed no significant difference between both arms
NEOTRANS
Sponsor study identifier
interventional
61
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 16, 2012
Actual (reported)February 22, 2012
Actual (reported)March 2016
Actual (reported)March 2016
Actual (reported)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
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
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
The protocol will pretend enema: instillation in the diaper the product under consideration, to make the two indistinguishable processes (time, odor, wicking diaper ...)
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nantes
Nantes, France
61 participants (actual enrollment reported by the registry).
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
May 11, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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