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The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.
It will be a double-blind randomized control trial, single center. The study will include neonates with a gestational age of less than or equal 32 weeks and a birth weight of less than or equal 1500 g, and will randomly assigned to two treatment groups (see below).
Infants will be randomized to equal-sized groups using block randomization with blocks of four. Stratified randomization for gender and gestational age will be included in the randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27 weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2) will give 6 strata, requiring 6 separate random number lists to achieve randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetaminophen group | Experimental | Babies who took acetaminophen |
|
| Placebo group (Dextrose 5) | Experimental | Babies who took placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | The first group will receive acetaminophen as the following
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo. | within the first week of age |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of neonatal sepsis in the premature babies who received acetaminophen | Corrected 40 weeks of gestational age or time of discharge will be used | |
| The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mountasser Al-Mouqdafd, MD | Contact | 00966539095090 | m.almouqdad@ksmc.med.sa |
| Name | Affiliation | Role |
|---|---|---|
| Mountasser Al-Mouqdad, MD | King Saud Medical City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountasser Al-Mouqdad | Recruiting | Riyadh | 11196 | Saudi Arabia |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
|
| Dextrose 5 | Drug | The second group will receive placebo (D5W) as the following
|
|
|
| Corrected 40 weeks of gestational age or time of discharge will be used |
| The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen | Corrected 40 weeks of gestational age or time of discharge will be used |
| Aniline Compounds |
| D000588 | Amines |