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comparison of two different techniques of changing blood with saline(partial exchange) for increase in red blood cells (polycythemia)in neonates

Continuous Arterio-Venous Exchange (CAVE) vs Pull -Push technique for Partial Exchange Transfusion in Polycythemic neonates- a Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002378
Enrollment
22
Registered
2012-01-25
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- polycythemic neonates who may or may not be symptomatic

Interventions

Intervention1: CAVE: Continuous Arterio-Venous Exchange (CAVE) technique will be done to do partial exchange in baby who is randomized in the group. This is a technique in which blood is allowed to l

Sponsors

Dr Praveen Kumar
Lead Sponsor
Dr sandeep S patil
Collaborator
Dr Sajan Saini
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All Infants inborn and out-born admitted in the Neonatal Unit of PGIMER Chandigarh requiring partial exchange transfusion for polycythemia will be prospectively enrolled after obtaining written informed consent from the parents

Exclusion criteria

Exclusion criteria: a) Presence of major congenital malformations. b) Negative Modified Allen?s test on both arms.

Design outcomes

Primary

MeasureTime frame
The key outcome variable will be Pain scores by N-PASS scoringTimepoint: The key outcome variable will be Pain scores by N-PASS scoring which will be done every one minute from the video recorded and repeated measure ANOVA will be utilised for analysis

Secondary

MeasureTime frame
Analysis will be also be done for effectiveness of the procedure by doing PCV at the end of procedure and 30 min and 2 hours after the procedure, time taken during the procedure, heart rate variation during the procedure, number of cannula block, local complications (like arm ischemia or erythema during or occurring within 72 hours post-procedure, incidence of IVH and cost of procedure which will be compared between two groups.Timepoint: 72hr

Countries

India

Contacts

Public ContactDr sandeep S Patil

PGIMER

drpkumarpgi@gmail.com01722755308

Outcome results

None listed

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