Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02149407
• Date of registration: 20/05/2014
• Prospective Registration: No
• Primary sponsor: King Saud Medical City
• Public title: Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants
• Scientific title: Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
• Date of first enrolment: May 2014
• Target sample size: 230
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02149407
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Saudi Arabia

Contacts

• Name: Jasim Anabrees

• Name: Latifa Almahmoud, MD
• Affiliation: KSMC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Preterm infants with birth weight equal or less than 1500 g

Exclusion Criteria:

- Significant congenital malformations

- Severity of illness such that death is likely in the first few days after birth



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Feeding Intolerance

Intervention(s)

Other: Control

Procedure: Rectal stimulation

Drug: Glycerin

Primary Outcome(s)

Time to full feeding (days) [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks]

Secondary Outcome(s)

Incidence of necrotizing enterocolitis (NEC) [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks]

Incidence of proven late onset infection [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks]

Length of hospital stay (days) [Time Frame: At discharge from hospital, an expected average of 8 weeks]

Incidence of feeding intolerance [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks]

Incidence of hyperbilirubinemia [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks]

Secondary ID(s)

0752

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sulaiman Al Habib Medical Group- Arrayan Hospital