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A study to find ability of reverse kangaroo care in decreasing pain in babies undergoing eye test to check the condition ROP

Effectiveness of reverse kangaroo mother care (rKMC) in reducing pain in neonates during retinopathy of prematurity (ROP) screening- An open labelled randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092503
Enrollment
60
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: ROP screening in rKMC position: The neonate is screened for ROP while on reverse kangaroo mother care (rKMC) position till its completion usually 2-10minutes Control Intervention1: ROP

Sponsors

AIIMS Bathinda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates who require ROP screening under GOI (RBSK 2017) guidelines. 2. Neonates either on room air or non-invasive respiratory support requiring FiO2 less than/equal to 30% at the time of ROP screening. 3. Neonates with weight more than 800 grams at the time of ROP screening regardless of mode of delivery, gestational age, singleton or twin status.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To determine the effectiveness of reverse KMC in reducing the pain during ROP screeningTimepoint: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum)—

Secondary

MeasureTime frame
Compare difference in PIPP-R scoreTimepoint: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum);Determine & compare mean change in Heart rate (HR), SpO2, Respiratory rate (RR) before & after procedure in rKMC vs Conventional armTimepoint: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum);Compare number of apnea episodes in rKMC vs Conventional armTimepoint: Before procedure (30-90 seconds after putting mydriatic agents), During procedure (30-90 seconds after speculum insertion), After procedure (30-90 seconds after removing speculum);Procedural time difference between both the armsTimepoint: From insertion of speculum and removal of speculum—

Countries

India

Contacts

Public ContactDr Vijaykumar

AIIMS Bathinda

dmanishswami@gmail.com9991909318

Outcome results

None listed

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