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very poor enrollment
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Objective of this study are:
1) To determine if medication help extreme preterm infants to tolerate feeding better by reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1) Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study after parental consent. Infant would be blinded to care givers. Infants will be randomized to receive one of three medication for 7-14 days. If infants fail on one medication they will be allowed to crossover to other medication. Infant would be allowed to treat like other infants. Blindness can be broken if deem necessary by attending neonatologist.
Inclusion Critera:
Exclusion Criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | This group of infant will not receive any medication but sugar water or placebo |
|
| Metclopramide | Active Comparator | This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs. |
|
| Erythromycin | Active Comparator | mediaction used to treat feeding disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metclopramide | Drug | Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL | Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding. | 24 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial. | Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia, | 24 months |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Darshan S Shah, MD | East Tennessee State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Tennessee State University | Johnson City | Tennessee | 37604 | United States |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D009748 | Nutrition Disorders |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Erythromycin | Drug | Dose of erythromycin is 1 miligram per kilogram every eight hours |
|
| placebo | Drug | The dose of sugar water is 1 ml per 8 hours. |
|
| D009750 | Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |