10 days vs 14 days antibiotic therapy in Gram negative bacterial sepsis in newborns.

Not Applicable

Conditions: Health Condition 1: null- NEONATES WITH BIRTH WEIGHT GREATER THAN 1500 GRAMS WITH BLOOD CULTURE SHOWING GRAM NEGATIVE BACTERIA

Registration Number: CTRI/2018/01/011453

Lead Sponsor: ONE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Neonates with gestational with birth weight > 1500 g, who satisfy all the following criteria will be enrolled:

i.Clinical signs of sepsis as per NEOKISS criteria present before antibiotic therapy (Appendix I) in addition to other signs

ii.Blood culture showing growth of a pathogenic GNB

iii.Repeat blood culture after 7 days of sensitive antibiotic therapy should be sterile

iv.Infant should be in remission defined as being on full feeds, not on mechanical ventilation (except high flow nasal cannulae) or on inotropes.

Exclusion Criteria

The following patients will be excluded:

1.Infants born with major congenital malformations such as diaphragmatic hermia, abdominal wall defects, neural tube defects, esophageal atresia with/without fistula etc.

2.Severe birth asphyxia (defined as APGAR score <3 at 5 minutes).

3.Infants being planned to be treated for neonatal meningitis as per attending neonatologist [ ].

4.Those undergoing or underwent major surgeries.

5.Infants with clinically evident bone (osteomyelitis) / joint (arthritis) [1].

6.Infants whose blood cultures were interpreted as â??contaminant or possible contaminantâ??.

7.Refusal of consent or unlikely to follow up for 28 days.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary 1.Treatment failur defined as positive blood culture for same organism within 28 days of antibiotic completion therapy.Timepoint: 28 days

Secondary Outcome Measures

Name	Time	Method
Secondary 1.Duration of hospital stay in days. 2.Complications of IV therapy such as extravasation injuries/phlebitis/hematoma. 3.Duration of mechanical ventilation/inotropic support/TPN.4.Need for blood products 5.Episodes of new onset sepsis (blood culture positive) by a different organism. 6.All cause mortality within 4 weeks of completion of antibiotic therapy.Timepoint: 28 days