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临床试验/CTRI/2022/12/047815
CTRI/2022/12/047815尚未招募不适用

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

未提供1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年10月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
Composite adverse outcome which includes death and Neurodevelopmental impairment after discharge within first 2 years of life

研究概览

简要总结

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†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

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
0.00 Month(s) 至 8.00 Month(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • •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.

结局指标

主要结局

Composite adverse outcome which includes death and Neurodevelopmental impairment after discharge within first 2 years of life

时间窗: 2 years

次要结局

  • Long term outcomes:(•weight at Corrected age of 1 year and 2 years)

研究者

发起方
未提供

研究点 (1)

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