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Comparison of two methods of intravenous cannulae fixation in newborns

Comparison of two method of cannulae fixation in neonates- a randomized unblinded study - RUCOM

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010872
Enrollment
300
Registered
2017-12-13
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- new born babies requiring peripheral intra venous line

Interventions

Intervention1: 10 cm flexible bi-extension tubing attachment to intravenous peripheral cannula: to compare the duration, extravasation and phlebitis between the two groups I. e. with and without exten

Sponsors

Apollo Cradle
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Term new born i.e. >= 37 weeks of gestational age. 2.Minimum birth weight 2500 gm. 3. No prior skin eruptions 4. No prior cannulation at the studied site 5. Age

Exclusion criteria

Exclusion criteria: 1.Preterm newborn (gestational age less than 37 weeks) 2.Low birth weight ( 2500 gms) 3.Skin eruptions at the study site 4.Prior cannulation at the study site (within 3 cm of the any previous cannulation) 5.Age more than 7days Infusion of drugs known to cause extravasations and phlebitis

Design outcomes

Primary

MeasureTime frame
Mean functional duration of cannula Timepoint: Mean functional duration of cannula

Secondary

MeasureTime frame
Incidence of extravasations Incidence of Phlebitis Timepoint: earliest when extravasation or phlebitis occurs that indicates time of cannula removal

Countries

India

Contacts

Public ContactDr Manish Balde

Apollo Cradle

swazir21@gmail.com9958283480

Outcome results

None listed

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