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| Name | Class |
|---|---|
| Sulaiman Al Habib Medical Group- Arrayan Hospital | UNKNOWN |
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Feeding intolerance is a common problem in preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerin group (GG) | Active Comparator | 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. |
|
| Rectal stimulation group (SG) | Active Comparator | 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. |
|
| Control group (CG) | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerin | Drug | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Growth at discharge from hospital | Growth parameters at discharge from hospital include: Weight (grams), Length (cm), and Head circumference (cm) | At discharge from hospital, an expected average of 8 weeks |
| Retinopathy of prematurity (ROP) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasim Anabrees | Contact | jasim1800@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Latifa Almahmoud, MD | KSMC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud Medical City | Recruiting | Riyadh | Saudi Arabia |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Rectal stimulation | Procedure | 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. |
|
| Control | Other | 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. |
|
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 |
Defined by the International Classification of Retinopathy of Prematurity (ICORP)
| Participants will be followed for the duration of hospital stay, an expected average of 8 weeks |
| Bronchopulmonary dysplasia (BPD) | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks |
| Patent ductus arteriosus (PDA) | Diagnosed by echocardiogram | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks |
| Side effects | For example: Rectal bleeding, Rectal Perforation, or Hematochezia | Participants will be followed for the duration of hospital stay, an expected average of 8 weeks |
| Sulaiman Al Habib Medical Group | Not yet recruiting | Riyadh | Saudi Arabia |
|
| D002241 |
| Carbohydrates |