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Effect of a Mother-Led Neurodevelopmental Care Program Compared with Kangaroo Mother Care on Growth and Development in Preterm Babies

Development, Validation and Effectiveness of the Mother Led Neurodevelopmental Module vs KMC Module on Neuromuscular Maturity and Weight Gain Trajectories in Preterm Neonates: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111780
Enrollment
62
Registered
2026-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: KMC: Participants allocated to the control group will receive standard Kangaroo Mother Care (KMC) according to WHO guidelines, including skin-to-skin positioning, breastfeeding support,

Sponsors

Datta Meghe Institute of Higher Education and Research DU Sawangi Meghe
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. High-risk neonatal graduates (preterm and/or medically high-risk) discharged from NICU 2. Corrected age within the early post-discharge period 3. Clinically stable and fit for handling/physiotherapy 4. Mother/primary caregiver available and willing for training + home sessions 5. Written informed consent and ascent (including consent for video recording)

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies or genetic syndromes affecting neurodevelopment 2. Severe neurological impairment diagnosed at baseline (e.g., major brain malformation/severe encephalopathy) 3. Medically unstable infants (acute illness/oxygen instability/contraindication to handling) 4. Severe sensory impairments that prevent testing (severe vision/hearing loss) 5. Family planning to relocate / unable to complete follow-up, or refusal for video recording

Design outcomes

Primary

MeasureTime frame
Alberta Infant Motor Scale (AIMS)Timepoint: Baseline, 4th Week

Secondary

MeasureTime frame
DeepLabcut, Caregiver Self Efficacy ScaleTimepoint: Baseline, 4th Week

Countries

India

Contacts

Public ContactDr Sharath Hullumani

DMIHER

sharathhullumani@gmail.com8010943039

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026