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Clinical Trials/CTRI/2020/03/023945
CTRI/2020/03/023945
Completed
未知

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

okmanyaTilak Municipal Medical College General Hospital Mumbai0 sites126 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: P29- Cardiovascular disorders originating in the perinatal period
Sponsor
okmanyaTilak Municipal Medical College General Hospital Mumbai
Enrollment
126
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
November 22, 2021
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
okmanyaTilak Municipal Medical College General Hospital Mumbai

Eligibility 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

  • 1\.Contraindications for the use of ibuprofen (active bleeding, especially intracranial hemorrhage within 48 hours or gastrointestinal bleeding, thrombocytopenia(platelet count \<60000/mm3, suspected NEC,significant impairment of renal function with serum creatinine \> 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

Outcomes

Primary Outcomes

Not specified

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