Skip to content

Role of bacterial filters in reducing the deaths and infection in newborns.

randomised controlled, open label study of in line bacterial filters for intravenous lines in reducing mortality and morbidity in newborns.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011778
Enrollment
144
Registered
2018-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Premature Newborns

Interventions

Intervention1: Neonatal/Paediatric 96 hour I.V. filter 0.22µm: filter for the removal of inadvertent microbial contaminants, associated endotoxins, particulates and air - Male and female Luer-lock fi

Sponsors

Lokmanya Tilak Municipal Medical College and General Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newborn babies between 28weeks to 34 weeks 2. Inborn Babies 3. Preterm babies who are expected to receive intravenous fluids for more than 72hours. 4. Parents willingly giving consent for participation in the study

Exclusion criteria

Exclusion criteria: 1. Not giving consent for participation 2. Babies on invasive ventilation. 3. Babies with risk of early onset sepsis in the form of maternal colonization with bacteria like group B streptococci, rupture of membranes >18 hours, and maternal signs or symptoms of intra-amniotic infection.(American Association Of Pediatrics Guidelines). 4. Babies having any congenital anamolies or surgical disease.

Design outcomes

Primary

MeasureTime frame
1. Proven â??Blood Stream Infectionâ?? by positive bacterial or fungal blood culture. 2. Mortality from proven sepsisTimepoint: 28 days of life

Secondary

MeasureTime frame
1. Localised complications 2. Duration of cannula patency 3. Number of catheters inserted. 4. Suspected septicaemic infection; clinical symptoms consistent with septicaemia but not proven. 5. Mortality of any cause 6. Proven necrotizing enterocolitis; Bellâ??s stage two or greater. 7. Suspected necrotizing enterocolitis (NEC) 8. Periventricular leukomalacia 9. Length of stay in hospital (days). 10. Bronchopulmonary Dysplasia 11. Retinopathy of prematurity 12. Adverse effectsTimepoint: 28 days of life

Countries

India

Contacts

Public ContactVinayak Vijay Kodur

L.T.M.General Hospital

jayashreemondkar@rediffmail.com7506190105

Outcome results

None listed

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