The effect of prescription versus not prescription of the prophylactic antibiotic on clinical outcomes in newborn with transient tachypnea

The effect of prescription versus not prescription of the prophylactic antibiotic on clinical outcomes in newborn with transient tachypnea: a triple blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201609049014N114

Enrollment

100

Registered

2016-09-08

Start date

2016-08-22

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

Transient tachypnea. Transient tachypnoea of newborn

Interventions

Intervention 1: Just routine care. Intervention 2: Routine care plus ampicillin 25 mg/kg 3 times a day for 72 hours and amikacin 10 mg/kg 2 times a day for 72 hours.

Treatment - Other

Treatment - Drugs

Just routine care

Routine care plus ampicillin 25 mg/kg 3 times a day for 72 hours and amikacin 10 mg/kg 2 times a day for 72 hours

Eligibility

Sex/Gender

All

Age

1 Days to 7 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonate with gestational age of 34 to 41 weeks; respiratory distress for at least 4 hours. Exclusion criteria: prenatal or perinatal infection; congenital anomalies; disposal of meconium during delivery; Apgar score of 7 or lower; pneumonia; indication of mechanical ventilation; signs of primary septicemia; need for additional oxygen with pressure more than 40%.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Assessing the incidence of pneumonia. Timepoint: on the first, second, and third days after intervention. Method of measurement: through physical examination.;Assessing the signs of septicemia. Timepoint: on the first, second, and third days after intervention. Method of measurement: through physical examination.;Assessing the incidence of death. Timepoint: on the first, second, and third day after intervention. Method of measurement: through physical examination.	—

Measure

Time frame

Assessing the incidence of pneumonia. Timepoint: on the first, second, and third days after intervention. Method of measurement: through physical examination.;Assessing the signs of septicemia. Timepoint: on the first, second, and third days after intervention. Method of measurement: through physical examination.;Assessing the incidence of death. Timepoint: on the first, second, and third day after intervention. Method of measurement: through physical examination.

—

Secondary

Measure	Time frame
Assessing duration of hospitalization. Timepoint: based on medical record. Method of measurement: at discharge.;Assessing blood culture. Timepoint: on the first, second, and third days after intervention. Method of measurement: through laboratory test.;Assessing adverse effect of medications such as renal failure. Timepoint: on the first, second, and third days after intervention. Method of measurement: through laboratory test.	—

Measure

Time frame

Assessing duration of hospitalization. Timepoint: based on medical record. Method of measurement: at discharge.;Assessing blood culture. Timepoint: on the first, second, and third days after intervention. Method of measurement: through laboratory test.;Assessing adverse effect of medications such as renal failure. Timepoint: on the first, second, and third days after intervention. Method of measurement: through laboratory test.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Leila Bahadorbeigi

Fatemieh Hospital

bahar_liela@yahoo.com+98 81 3828 3939

Outcome results

None listed

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