Skip to content

Role of aminophylline in kidney function of babies who did not cry after birth.

Role of aminophylline in renal dysfunction of asphyxiated neonates: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030380
Enrollment
30
Registered
2021-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N179- Acute kidney failure, unspecified

Interventions

Intervention1: Drug : aminophylline: Babies fulfilling the inclusion criteria will receive 1 dose of injection aminophylline within 1 hour of life depending upon the random code number. Control Interv

Sponsors

Mohit Bansal
Lead Sponsor
Swami Dayanand hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates �37 weeks Appropriate for Gestational Age(AGA), who have birth asphyxia manifested by any of the following : 1. H/o fetal distress(late decelerations, decreased heart rate variability, or bradycardia). 2. Apgar score of � 3 at 1 minute or � 5 at 5 minutes. 3. Base deficit equal to or greater than 15mEq/l in cord blood or admission ABG/VBG samples. 4. Requirement of immediate positive pressure ventilation with bag and mask or intubation with endotracheal tube for >1 minute after delivery.

Exclusion criteria

Exclusion criteria: 1. Antenatally diagnosed congenital abnormalities of the kidney and/or urinary tract. 2. CVS abnormalities not related to perinatal asphyxia. 3. Prenatal or neonatal exposure to medications that might have modified renal hemodynamics. 4. Any gross congenital malformation or chromosomal abnormality.

Design outcomes

Secondary

MeasureTime frame
Incidence of adverse events following aminophylline administration like tachycardia, hyperglycemia, and vomiting.Timepoint: till 24 hours post aminophylline injection.;Outcome of neonates in both groups in terms of I. Duration of hospital stay II. Mortality Timepoint: birth to discharge from hospital.;Severity of AKI as per neonatal Kidney Disease Improving Global Outcome (KDIGO) criteria.Timepoint: birth to 5 days of life

Primary

MeasureTime frame
Renal function as per measurement of : 1. Serum creatinine 2. urine output 3. creatinine clearanceTimepoint: At 24 hours, 72 hours, and 120 hours of life in both groups.

Countries

India

Contacts

Public ContactMohit Bansal

MBBS MD PEDIATRICS

anilsaini.0410@gmail.com9810075126

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026