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

Infant, Very Low Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01799629
• Other study ID #: 2121 110
• Status: Terminated
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2022

Study information

• Verified date: March 2024
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

1. Preterm infants with birth weight < 1250g.

2. Inborn or outborn infants

3. Less than 72 hours of age.

Exclusion Criteria:

1. Congenital malformations.

2. Acute abdomen needing surgical intervention.

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

4. Inability to get the parental consent.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Infant, Very Low Birth Weight

Intervention

Drug:
• Glycerin suppositories

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Centre	Riyadh
Saudi Arabia	Security Forces Hospital	Riyadh
Saudi Arabia	Sulaiman Al habib Medical Center	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center	Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)		2years
Secondary	Incidence of feeding intolerance	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.	2years
Secondary	Incidence of necrotizing enterocolitis (NEC)		2years