Short-term and long-term outcomes of “Developmental and Supportive Care Interventions Bundle†in preterm neonates
- Conditions
- Preterm [premature] newborn [other],
- Registration Number
- CTRI/2022/12/047815
- Brief Summary
Preterm neonates require highly specialized developmental care which involves adjusting the neonatal intensive care unit to reduce stress and improve optimal brain and behavioral development of the preterm neonate. A Prospective Longitudinal interventional study will be conducted in Neonatal Intensive Care Unit (NICU). Neonatal Intensive Care Unit is situated in the 3rd floor Nehru hospital, PGIMER, Chandigarh. Preterm neonates less than 32 weeks will be enrolled as Control and intervention group (150 each) after assessing for inclusion and exclusion criteria. a pilot study will be conducted to assess the feasibility. The study will not involve any alteration in investigations, treatment and routine care of any patient. Additional interventions are likely to improve the short term and long-term outcomes. All staffs of the NICU will be informed about the study and will be trained to provide the bundle care. The purpose of the study will be explained to the parents of preterm neonates and will be assured of confidentiality. A written informed consent will be obtained from the parents of preterm neonates and parents will be given full authority to take decision for their participation and they could withdraw from the study at any point without any adverse effect on their subsequent care. Mother will be involved in day-to-day care of the stable neonate (nappy changes, cleaning etc.) Pre-intervention data will be collected in control group before the implementation of intervention bundle. For Implementation of “Developmental and Supportive Care Interventions Bundle**â€** regular and frequent sessions of teaching, demonstration and training of health care providers and mothers of preterm-neonates will be conducted by researcher till overall coverage. post discharge follow-ups will be conducted on set time periods. At the time of discharge pre-discharge clinical assessment will be done which include mode of feeding at discharge, type of feed, weight at discharge, head circumference, length and short version hammersmith neonatal neurodevelopmental examination. Anthropometric assessment will be performed at the age of 3,6,9,12,18 and 24 months. At corrected age of 12±2 months and 24±3 months, babies will be tested by DASII scale and hammersmith infant neurodevelopmental examination. At chronological age of 2 years behavior will be assessed by preschool behavioural checklist
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 300
- Inborn pre-term neonates with gestational age of less than 32 weeks.
- Inborn pre-term neonates admitted in NICU within 7 days of birth.
- 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.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite adverse outcome which includes death and Neurodevelopmental impairment after discharge within first 2 years of life 2 years
- Secondary Outcome Measures
Name Time Method Long term outcomes: •weight at Corrected age of 1 year and 2 years
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012🇮🇳Chandigarh, CHANDIGARH, IndiaUrmilaPrincipal investigator9814452228yadav.urmila593@gmail.com