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临床试验/CTRI/2025/01/079822
CTRI/2025/01/079822
尚未招募
不适用

Clinical and antenatal profile in late pre term and term neonate A cross sectional study

DR DEVESH AGRAWAL1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年2月17日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
DR DEVESH AGRAWAL
入组人数
76
试验地点
1
主要终点
To compare the clinical and antenatal profile in Late Pre-Term and Term neonate.

概览

简要总结

Parents or guardians of all the neonates shall be invited to participate in study. who will give consent to participate in study shall be enrolled in the study.

Detailed Methodology

The Date of the Last Menstrual Cycle and early obstetric Ultrasonography Scan 6-12 weeks will be used to estimate gestation if available.

The Expanded New Ballard score will be used for infants delivered on uncertain dates or in which LMP or USG not available. From the time of delivery until discharged, the newborns will be subjected to daily clinical examinations. All the newborns in the study will be treated according to their clinical status on case to case basis by respective units.

In a structured Proforma all clinically relevant data will be recorded.

Till Discharge all newborns included in the study will be assessed daily for any morbidity, and data will be entered into clinical records.

 Parameters recorded for the study

1     Information of Mother: which will include Pre-natal and Natal History.

 Pre-Natal History will include- Mothers Age, family background, singleton or multiple births, pre-natal information like- PROM, Polyhydramnios, hypertension, gestational diabetes mellitus, maternal infection etc.

 Natal History will include time of true labour pains, duration of rupture of membrane, indication of pre-term delivery, delivery mode- Normal Vaginal Delivery or Lower Segment Cesarian Section (LSCS)

 2     Neonatal Parameter will include- Weight for gestation, gender, weight at birth, APGAR score at 1min, 5min

In case of NICU admission, details will be taken such as cause of NICU admission Respiratory difficulties and Requirement of Ventilation, Nenonatal Hyperbilurubinemia, Hypothermia, Hypoglycemia, Sepsis, Requirement of IV medications, feeding problems

Any re-admission within one week after discharge and cause for readmission after discharge will be recorded.

 Discharge or Mortality will be recorded.

 Definitions

Hypoglycemia- It is defined as a blood glucose value of less than 40 mg/dL plasma glucose less than 45 mg/dL

Hypothermia- Body Temperature Less than 36.5 C

Cold stress or mild hypothermia 36.0 to 36.4 C

Moderate hypothermia: 32 to 35.9°C

Severe hypothermia: <32°C.

 Feeding ProblemsInadequate feeding

 Hyperbilirubinemia- Total Serum Bilirubin TSB levels have been arbitrarily defined as, Pathological, if it exceeds 5 mg/ dL on first day, 10 mg/ dL, on second day, or 15 mg/ dL thereafter in term babies.

Presence of any of the following signs indicates

pathological jaundice:

Clinical jaundice detected before 24 hours of age

Rise in serum bilirubin by more than 5 mg/ dL/ day

Serum bilirubin more than 15 mg/dL

Clinical jaundice persisting beyond 14 days of life

Clay-/white-colored stool and/or dark urine staining

the clothes yellow

Direct bilirubin >2 mg/ dL at any time.

 Neonatal Sepsis- It is a clinical syndrome characterised by infection-related signs and symptoms in the first month of life, either with or without bacteremia. It includes different infant systemic illnesses like septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and UTI.

Perinatal Asphyxia- World Health Organisation WHO Failure to initiate and Sustain breathing .

National Neonatal Perinatal Database Moderate Perinatal Asphyxia- Slow/Gasping Breathing   or an APGAR score of 4-6 at 1 minute

Severe Perinatal Asphyxia- No breathing or an APGAR score of 0-3 at 1 minute of birth.

  Details which will be recorded at time of discharge- Weight of baby, length, Head Circumference, Duration spent in hospital, final Diagnosis.

 Babies will be followed up in OPD for routine checkup and evaluation till neonatal period first 28 days of life

 Families will be contacted via Phone to Enquire about the health status, including Compulsory OPD visit on Day 7 and Day 28 of life.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 20.00 Day(s)(—)
性别
All

入选标准

  • Cases All late preterm neonates who will be admitted in our Neonatal Intensive Care Unit or Post Natal Ward will be included.
  • Control All term neonates born OR admitted during the study period will be included as control group.
  • Patients attendant who will give informed and written consent for enrollment into study.

排除标准

  • Preterm babies Neonates born with Gross Congenital deformities Patient’s attendant who will not give informed consents.

结局指标

主要结局

To compare the clinical and antenatal profile in Late Pre-Term and Term neonate.

时间窗: At baseline

次要结局

  • Compare the clinical profile of Late pre-term and Term Neonate.(To study the antenatal risk factors in Late pre-term with Term neonate.)

研究者

发起方
DR DEVESH AGRAWAL
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Devesh Agrawal

Rohilkhand Medical College

研究点 (1)

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