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Comparison of feeding or not feeding the premature babies when they are given oral drug ibuprofen and evaluate the time to reach full feeds in two groups.

Comparison of enteral feeding versus no feeding in preterm babies less than 30 weeks of gestation on time to reach full feeds during the treatment of patent ductus arteriosus with oral Ibuprofen - DAFNI Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023945
Enrollment
126
Registered
2020-03-13
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: P29- Cardiovascular disorders originating in the perinatal period

Interventions

Intervention1: Feeding the babies with Minimal Enteral nutrition: Babies who will be treated with oral ibuprofen for Patent Ductus Arteriosus will be given Minimal Enteral nutrition @ 15ml/kg/day for

Sponsors

LokmanyaTilak Municipal Medical College General Hospital Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm babies less than 30 weeks of gestation with hemodynamically significant patent ductus arteriosus (PDA) on trearment with oral Ibuprofen.

Exclusion criteria

Exclusion criteria: 1. Contraindications for the use of ibuprofen (active bleeding, especially intracranial hemorrhage within 48 hours or gastrointestinal bleeding, thrombocytopenia(platelet count 1.5 mg/dl) 2. Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow 3. Major congenital anomalies. 4. Chromosomal anomalies 5. Congenital or acquired gastrointestinal anomalies 6. Prior episodes of necrotizing enterocolitis or intestinal perforation 7. Severe shock requiring > 2 Inotropes for hypotension at the time of entry 8. Treatment of PDA after first week of life 9. Babies on maximal enteral nutrition > 60 ml/kg/ day

Design outcomes

Primary

MeasureTime frame
Time taken to reach full feeds ( 120 ml/kg/day)Timepoint: Time taken to reach full feeds ( 120 ml/kg/day)—

Secondary

MeasureTime frame
1.Number of episodes of feed intolerance 2.NEC/ spontaneous intestinal perforation prior to reaching 120 ml/k/d 3.NEC/ spontaneous intestinal perforation any time during hospitalization 4.Number of days of respiratory support 5.Number of days of hospitalization 6.Number of babies with sepsis 7.Mortality 8.Intraventricular hemorrhage (grade 2 according to Volpe classification) 9.Periventricular leukomalacia 10. BPD 11.ROP stage 2 as defined by international classification Timepoint: Till death or discharge of patient—

Countries

India

Contacts

Public ContactDr Swati Manerkar

LokmanyaTilak Municipal Medical College & LokmanyaTilak Municipal General Hospital, Mumbai

dr.samandeep@gmail.com7015539650

Outcome results

None listed

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