Prophylactic aminophylline for prevention of apnea in preterm neonate with weight less than 1200 gr.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013052610026N1

Enrollment

Registered

2013-08-15

Start date

2012-03-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Apnea. Primary sleep apnoea of newborn

Interventions

Intervention 1: In the aminophylline given group (A), after considering the inclusion and exclusion criteria for the premature neonate with a weight equal and lower than 1200 gr. who is breathing spon

Prevention

In the aminophylline given group (A), after considering the inclusion and exclusion criteria for the premature neonate with a weight equal and lower than 1200 gr. who is breathing spontaneously at age

In control group (C), after considering the inclusion and exclusion criteria for the premature neonate with a weight equal and lower than 1200 gr. who is breathing spontaneously at age 24 hours, no

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria are infants born premature and at birth weight equal and lower than 1200 grams and spontaneous breathing at age 24 hours. Infants who have major congenital anomalies; asphyxia; occurrence of apnea and need to mechanical ventilation in first 24 hours of birth; congenital cyanotic heart disease and sepsis in the first seven days of birth will excluded.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Cyanosis. Timepoint: 10 days. Method of measurement: nursing documentation and monitor download.;Bradycardy. Timepoint: 10 days. Method of measurement: nursing documentation and monitor download.;Apnea. Timepoint: 10 days. Method of measurement: nursing documentation and monitor download.	—

Secondary

Measure	Time frame
CPAP. Timepoint: 10 days. Method of measurement: daily recorded sheets.;Hospital stay. Timepoint: 10 days. Method of measurement: daily recorded sheets.;Death. Timepoint: During Hospital stay. Method of measurement: daily recorded sheets.;Mechanical ventilation. Timepoint: 10 days. Method of measurement: daily recorded sheets.;Oxygen dependency time. Timepoint: During Oxygen dependency time. Method of measurement: daily recorded sheets.;Side effects. Timepoint: 10 days. Method of measurement: daily recorded sheets.	—

Measure

Time frame

CPAP. Timepoint: 10 days. Method of measurement: daily recorded sheets.;Hospital stay. Timepoint: 10 days. Method of measurement: daily recorded sheets.;Death. Timepoint: During Hospital stay. Method of measurement: daily recorded sheets.;Mechanical ventilation. Timepoint: 10 days. Method of measurement: daily recorded sheets.;Oxygen dependency time. Timepoint: During Oxygen dependency time. Method of measurement: daily recorded sheets.;Side effects. Timepoint: 10 days. Method of measurement: daily recorded sheets.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Raha Afghari

Isfahan University of Medical Sciences

golgoonehafghari@yahoo.com+98 31 1630 7533

Outcome results

None listed

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