Influence of Erythromycin ethyl succinate oral on establishment of feeding in preterm infants

Randomize clinical trial on determining the effect of Erythromycin on the establishment of feeding in infants under 32 weeks gestation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015121925591N1

Enrollment

Registered

2016-06-12

Start date

2015-08-23

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

Premature infants. Perinatal digestive system disorder, unspecified

Interventions

Intervention 1: Intervention group: Erythromycin Ethyl Succinate oral (10 mg per kg every six hours to two days, followed by 4 mg per kg every six hours to 5 days). Intervention 2: Control group: Norm

Treatment - Drugs

Placebo

Intervention group: Erythromycin Ethyl Succinate oral (10 mg per kg every six hours to two days, followed by 4 mg per kg every six hours to 5 days)

Control group: Normal saline (placebo) (10 mg per kg every six hours to two days, followed by 4 mg per kg every six hours to 5 days)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Infants less than 32 weeks gestational age or weighting less than 1800 g with minimum age of 5 days and clinically stable (Normal blood pressure, not having episodes of bradycardia and hypoxemia); Feeding intolerance for less than 75 milliliters per kilogram per day in 14 days; material remaining in the stomach for more than 50% in 3 hours before, which occurred at least two times during the 24 hours; Vomiting more than 30% of gastric residues in 3 hours that happened at least three times Exclusion criteria: Lethal congenital malformations congenital or chromosomal disorders; Cyanotic heart disease; Diseases of the gastrointestinal tract obstruction (Mal rotation, Atresia and Omphalocele, etc.); Gastrointestinal surgeries in 14 days ago; NEC suspected or confirmed in the last 7 days; Definite or clinical sepsis; Metabolic disorders or electrolytic; Treatment with any of the following medications at the onset of feeding intolerance (Fentanyl , Indomethacin, Pancuronioum)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Feeding tolerance of preterm infants. Timepoint: 5 days after birth less than 32 weeks, less than 1800 gr. Method of measurement: Weight.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Saboute

Ali Asghar Children Hospital

saboutem@yahoo.com+98 21 5563 2277

Outcome results

None listed

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