Infant, Very Low Birth Weight
Conditions
Keywords
Glycerin suppositories, Feeding intolerance, preterm infants, prophylactic use, elimination of meconium
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
Interventions
DRUGGlycerin suppositories
Sponsors
Dr. Sulaiman Alhabib Medical City, Riyadh
Security Forces Hospital
King Faisal Specialist Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) | 2years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of feeding intolerance | 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) | 2years | — |
Countries
Saudi Arabia
Outcome results
None listed