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
NCT number | NCT01799629 |
Other study ID # | 2121 110 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | December 2022 |
Verified date | March 2024 |
Source | King Faisal Specialist Hospital & Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center | Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital |
Saudi Arabia,
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 |
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