Clinical Trial: Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

Brief Summary: To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants

Detailed Summary:
Sponsor: King Faisal Specialist Hospital & Research Center

Current Primary Outcome: days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) [ Time Frame: 2years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence of feeding intolerance [ Time Frame: 2years ]
  which is defined by the presence of GRVs > 50 % of the previous feed for two consecutive feeds in addition to two of the following: I. Abdominal distention > 1 cm in 12 hour. II. Abdominal tenderness. III. Vomiting. IV. Bile stained aspirate.
• Incidence of necrotizing enterocolitis (NEC) [ Time Frame: 2years ]

Original Secondary Outcome: Same as current

Information By: King Faisal Specialist Hospital & Research Center

Dates:
Date Received: February 25, 2013
Date Started: March 2013
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016