Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

Study Overview
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Brief Summary
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Feeding intolerance is a common problem in preterm infants.

Official Title
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Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants

Conditions
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Feeding Intolerance

Intervention / Treatment
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* Drug: Glycerin
* Procedure: Rectal stimulation
* Other: Control


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glycerin group (GG)<br>Glycerin group GG will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery. | Drug: Glycerin<br>* Glycerin group GG will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery.<br>* Other names: Glycerine;|
| Active Comparator: Rectal stimulation group (SG)<br>Rectal stimulation SG by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall. | Procedure: Rectal stimulation<br>* Rectal stimulation SG by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall.<br>|
| Sham Comparator: Control group (CG)<br>Control group CG will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes. | Other: Control<br>* Control group CG will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to full feeding (days) | Days to achieve full enteral feeding | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of feeding intolerance | Feeding intolerance defined as feeding withheld, discontinued, or decreased because the infant was not tolerating enteral feedings. | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Incidence of necrotizing enterocolitis (NEC) | Necrotizing enterocolitis (NEC) defined as per Bell's staging. | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | 
| Incidence of proven late onset infection | Incidence of proven late onset infection defined as clinical signs in addition to positive blood culture beyond 72 hours of age. | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | 
| Incidence of hyperbilirubinemia | Incidence of hyperbilirubinemia defined as level of bilirubin requiring treatment with phototherapy according to the bilirubin chart used in the participating unit. | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks | 
| Length of hospital stay (days) |  | At discharge from hospital, an expected average of 8 weeks |