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Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. This study aims to fill this critical gap by comparing the efficacy of early caffeine administration versus supportive therapy in preventing AKI in preterm neonates.
There remains a debate about whether early initiation of caffeine therapy reduces the incidence and severity of AKI in preterm neonates compared to standard supportive care or not. Therefore, the incidence of AKI in preterm neonates will be compared between those receiving early caffeine therapy versus those receiving standard supportive therapy. The findings of this study would not only be a valuable addition to the statistics but also help clinicians to go for a better option in preterm neonates to prevent AKI, resulting in reducing the duration of mechanical ventilation, length of hospital stays, and all-cause neonatal mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Caffeine Group | Experimental | Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose. |
|
| Supportive Care Group | Experimental | Neonates will be given supportive care without caffeine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury | Incidence of AKI within the first 14 days of life. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Acute Kidney Injury | Time duration between onset of AKI and resolution. | Up to 30 days |
| Length of Hospital Stay | Time duration from admission to discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazia Fatima, FCPS | The Children's Hospital & The Institute of Child Health, Multan | Principal Investigator |
| Rabia Saleem, FCPS | The Children's Hospital & The Institute of Child Health, Multan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital & The Institute of Child Health | Multan | Punjab Province | 66000 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Supportive care | Drug | Neonates will be given supportive care without caffeine. |
|
| Up to 30 days |
| Mortality | Mortality will be labelled when a patient expires during a hospital stay. | Up to 30 days |
| D000091642 | Urogenital Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |