Aminophylline in Neonates with Moderate to Severe Asphyxia undergoing Therapeutic Hypothermia: A Randomized Controlled Clinical Trial.

Aminophylline in Preventing Renal Dysfunction among Asphyxiated Neonates undergoing Therapeutic Hypothermia: A Randomized Controlled Clinical Trial.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046291

Enrollment

Registered

2022-10-10

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: P039- Newborn affected by complication of labor and delivery, unspecified

Interventions

Intervention1: Aminophylline Drug: intravenous loading dose of 5 mg/kg (equivalent to 3.9 mg/kg theophylline), followed by maintenance dose of 2 mg/kg (equivalent to 1.5 mg/kg theophylline) every 8 ho

Eligibility

Inclusion criteria

Inclusion criteria: All neonates born above 36 weeks of gestation with evidence of intrapartum asphyxia (APGAR score: 12mmmol/L) and presence of moderate or severe hypoxic-ischemic encephalopathy as per modified Sarnat and Sarnat staging undergoing Therapeutic Hypothermia are included.

Exclusion criteria

Exclusion criteria: Neonates < 36 weeks and birth weight <1.8 kg with evidence of intrapartum asphyxia are excluded from the study.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of aminophylline in neonates with moderate to severe encephalopathy undergoing Therapeutic Hypothermia. Timepoint: at 12 Hours of Life at 72 Hours of Life	—

Secondary

Measure	Time frame
2. To assess optimal dosing strategies, importance of timing and duration of exposure of aminophylline, in neonates with moderate to severe encephalopathy during Therapeutic Hypothermia.Timepoint: at 12 Hours of Life at 72 Hours of Life	—

Countries

India

Contacts

Public ContactDR SIDDU CHARKI

BLDE(DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, VIJAYAPURA

sidducharki@bldedu.ac.in919008002974

Outcome results

None listed

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