Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assesses the efficacy of melatonin in treatment of feeding intolerance in preterm infants, the time needed to reach full enteral intake, the incidence of necrotizing enterocolitis and measures the level of tumor necrosis factor-alpha as a marker of oxidative stress.
This is a prospective study held on ninety preterm infants in Ain Shams University neonatal intensive care units. All enrolled neonates were suffering from feeding intolerance in the form of abdominal distension, gastric residuals or bloody stools. The first group of forty five infants were given melatonin in addition to traditional antibiotic treatment. The second group of forty five infants were given traditional antibiotic treatment only. Both groups were followed up clinically as regards improvement of clinical signs of feeding intolerance and laboratory results till they reached full enteral intake. Both groups were compared as regards incidence of necrotizing enterocolitis and level of tumor necrosis factor-alpha after 72 hours of starting treatment as a marker of oxidative stress.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment. |
|
| Group II | Sham Comparator | Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 20 mg | Drug | Melatonin was given as a total dose of 20 mg via enteral route in two doses of 10 mg each with a 1 hour interval in between. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants | Melatonin efficacy in treatment of oxidative stress in preterm infants with feeding intolerance was assessed by measuring level of tumor necrosis factor- alpha. | 3 days |
| Melatonin efficacy in reducing incidence of necrotizing enterocolitis in preterm infants | Melatonin efficacy in reducing incidence of necrotizing enterocolitis by radiological criteria: abdominal ultrasound showing pneumatosis intestinalis. | 1 week |
| Effect of melatonin on time needed to reach full enteral intake in preterm infants with feeding intolerance | Preterm infants with feeding intolerance were observed for the time needed to reach full enteral intake. | 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Pediatrics Department | Cairo | Abbasia | 11511 | Egypt |
Study protocol and informed consent form will be available upon reasonable request.
Within 6 months after finishing the study
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Traditional antibiotic treatment | Drug | Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University |
|
|
| D000091642 | Urogenital Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |