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A study comparing the pain experienced by neonates during heel prick using an automatic lancet and a 22 gauge needle using a standard pain score and the expected outcome of the study is that automatic lancet is having less pain than needle so that it can be used in NICU protocols

Comparative study of Neonatal Pain During Heel Prick Using an Automatic Lancet Versus 26-Gauge Needle:A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099658
Enrollment
126
Registered
2025-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

None listed

Interventions

Intervention1: HEEL PRICK: HEEL PRICK IS DONE FOR CHECKING BLOOD SUGAR IN NEONATES. DURING THE PROCEDURE ONE GROUP OF NEONATES WILL GET PRICKED WITH AUTOMATIC LANCET AND THE OTHER WITH 26 GAUGE NEEDLE

Sponsors

AISWARYA S KOTTOOR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ALL NEONATES BORN IN VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL REQUIRING SUGAR MONITORING LIKE INFANT OF DIABETIC MOTHER SMALL FOR GESTATIONAL AGE BABIES LOW BIRTH WEIGHT BABIES BABIES WHOSE MOTHERS ARE HAVING POOR SECRETION

Exclusion criteria

Exclusion criteria: BABIES WITH VERY LOW BIRTH WEIGHT ON MECHANICAL VENTILATION CONGENITAL ANOMALIES SEVERE MEDICAL OR SURGICAL CONDITIONS PRIOR PRICKS IN PAST 24 HOURS PARENTAL REFUSAL

Design outcomes

Primary

MeasureTime frame
EXPECTED OUTCOME IS THAT PAIN SCORE WILL BE LESS FOR NEONATES PRICKED WITH AUTOMATIC LANCET AND THE DEPTH OF PRICK AND PRECISION IS WELL CONTROLEDTimepoint: 5 MINUTES VIDEO OF PROCEDURE WILL BE TAKEN SUCH THAT INSTRUMENT WILL BE MASKED WHICH INCLUDE THE PERIOD BEFORE DURING AND AFTER THE PRICK VITALS MONITOR ALSO INCLUDED VIDEO WILL BE ACCESSED BY STUDY GUIDE ON THE SAME DAY OF PROCEDURE ACCESSMENT PART DONE BY GUIDE SO AS TO AVOID OBSERVER BIAS—

Secondary

MeasureTime frame
MORE AUTONOMIC STABILITY (LESSFLUCTUATION IN HEART RATE AND OXYGENSATURATION) IN NEONATES PRICKED WITH AUTOMATIC LANCET COMPARED TO THOSE PRICKED WITH 26 GAUGE NEEDLETimepoint: VITALS WILL BE MONITORED WITH MASIMO MONITOR BEFORE DURING AND 1 MIN AFTER THE PROCEDURE;LESS REPUNCTURE RATE NUMBER OF SQUEEZES IN NEONATES PRICKED WITH AUTOMATIC LANCETTimepoint: WILL BE ASSESSED DURING THE PROCEDURE;LESS LOCAL COMPLICATIONS LIKE SKIN TRAUMA BLEEDING FOR NEONATES PRICKED WITH AUTOMATIC LANCETTimepoint: COMPLICATIONS WILL BE OBSERVED POST PROCEDURE AND RECORDED IN A VEDIO FOR ACCESSOR TO COMMENT ON—

Countries

India

Contacts

Public ContactAISWARYA S KOTTOOR

VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL

sreenu77@gmail.com9994854115

Outcome results

None listed

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