Effect of intravenous Aminophylline injection on preventing renal dysfunction

Effect of intravenous Aminophylline injection on preventing renal dysfunction in the first living hours in neonates with asphyxia: A randomized clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181201041815N1

Enrollment

Registered

2019-01-15

Start date

2016-05-21

Completion date

Unknown

Last updated

2019-01-29

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

Conditions

Recovery of moderate to severe asphyxia in newborns. Asphyxia and hypoxemia

Interventions

Intervention 1: Intervention group: were administered one dose of 5 mg/kg slow intravenous Aminophylline injection during 5 minutes. Intervention 2: Control group: The control group was administered 2

Eligibility

Sex/Gender

All

Age

No minimum to 30 Days

Inclusion criteria

Inclusion criteria: Neonate with Moderate and Severe Asphyxia

Exclusion criteria

Exclusion criteria: Congenital Anomalies Prematurity(Gestational age=37 week)

Design outcomes

Primary

Measure	Time frame
The neonates’ fluid intake. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.;Urine volume in the first three days,. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.;Serum electrolytes including Sodium, Potassium, Calcium, serum Creatinine. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.;GFR. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.	—

Measure

Time frame

The neonates’ fluid intake. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.;Urine volume in the first three days,. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.;Serum electrolytes including Sodium, Potassium, Calcium, serum Creatinine. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.;GFR. Timepoint: Before and after the intervention 24 hours after intervention and during the 4th and 7th day of life. Method of measurement: Using Schwartz's formula, in two studied groups.

—

Secondary

Measure	Time frame
Lung disease. Timepoint: During the 4th and 7th day of life. Method of measurement: Chest X ray.;Intra Ventricular Hemorrhages seizure. Timepoint: During the 4th and 7th day of life. Method of measurement: Brain sonography and nursing documentation related to seizure.;Death. Timepoint: During the 4th and 7th day of life. Method of measurement: Shift documentation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Khalessi

Iran University of Medical Sciences

nasrinkhalessi@yahoo.com+98 21 86701

Outcome results

None listed

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