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Short-term and long-term outcomes of â??Developmental and Supportive Care Interventions Bundleâ?? in preterm neonates

To assess the short-term and long-term outcomes of â??Developmental and Supportive Care Interventions Bundleâ?? in preterm neonates less than 32 weeks admitted in the Neonatal Intensive Care Unit, PGIMER, Chandigarh

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047815
Enrollment
300
Registered
2022-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: Development of â??Developmental and Supportive Care Interventions Bundleâ??: it involves set of interventions applied in NICU on preterm neonates with gestational age of 32 weeks by mo

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn pre-term neonates with gestational age of less than 32 weeks. 2. Inborn pre-term neonates admitted in NICU within 7 days of birth. 3. Parents of inborn pre-term neonates residing in or within 100km radius of Chandigarh and are willing to come for follow up for at least 2 years after discharge

Exclusion criteria

Exclusion criteria: •Major congenital malformations. •Syndromic neonates •Proven intrauterine infection •Sever perinatal asphyxia (APGAR score at 5 min is 0-3) •Known case of visual and hearing abnormality diagnosed prior to enrolment. •Pre-tern neonates whose mother has died or mentally impaired or not willing to participate.

Design outcomes

Primary

MeasureTime frame
Composite adverse outcome which includes death and Neurodevelopmental impairment after discharge within first 2 years of lifeTimepoint: 2 years

Secondary

MeasureTime frame
Long term outcomes: â?¢weight at Corrected age of 1 year and 2 years â?¢Head Circumference and length at Corrected age of 1 year and 2 years â?¢Prevalence of seizure or epilepsy within first 2 years of life â?¢Preschool behavior outcomes Short term outcomes: â?¢Reductions in Stress behavior signs during NICU stay â?¢Improvement in â??Infant Positioning Assessment Tool score during NICU stay â?¢Weekly Weight gain, weight at discharge. â?¢Head Circumference and length at discharge. â?¢Transition time from oro-gastric tube feed to spoon feed and from spoon feed to direct breast feed Timepoint: 2 years

Countries

India

Contacts

Public ContactUrmila

Post Graduate Institute of Medical Education and Research, Chandigarh

kanyapgi@gmail.com9914208317

Outcome results

None listed

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