Role of Lactoferrin in Prevention of Ventilator Associated Pneumonia in Neonates.

Condition(s) studied

Investigational drug(s) / intervention(s)

Lactoferrin in prevention of VAP: oral dose separate from feeds \[at a daily dose of 100mg/day\] via orogastric tube from first day of enrollment till time of successful extubation plus standard preventive measures of VAP; these include semi recumbent position, hand washing, suctioning when needed, endotracheal tube with subglottic secretion drainage, using heat and moisture exchanger filter, oral hygiene, changing of tubes only when needed and changing of ventilator circuit every 5 days.

Control: They will receive standard preventive VAP strategies only.

Study summary

The aim of the study is to

1. Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates.
2. Evaluate the Primary outcome of Lactoferrin on:

Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea
3. Evaluate the effect of Lactoferrin in critically ventilated neonates on:

Incidence of VAP Duration of mechanical ventilation Duration of hospital stay

Eligibility

Primary outcome measure(s)

• Prevention of VAP — From enrollment until day 28 of life or NICU discharge, whichever occurs first.
  Diagnosis of VAP using the CDC/NHSN clinical and radiological criteria for neonatal ventilator-associated events. Outcome measured as the percentage (%) of enrolled neonates who develop VAP during NICU stay or up to 28 days of life.
• Prevention of VAP — during NICU stay
  Incidence of ventilator-associated pneumonia during mechanical ventilation.

Trial sites (1)

Other trials for the same condition