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CTRI Number  CTRI/2025/01/079822 [Registered on: 31/01/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Profile of late pre term and term neonate 
Scientific Title of Study   Clinical and antenatal profile in late pre term and term neonate A cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devesh Agrawal 
Designation  Junior resident 
Affiliation  Rohilkhand Medical College 
Address  3012, Department of pediatrics, Rohilkhand medical college, Pilibhit bypass road, Pawan vihar, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  7011167866  
Fax    
Email  DEBUDEVESH2000@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Lata Rai 
Designation  Professor and Head of department 
Affiliation  Rohilkhand Medical College 
Address  3012, Department of pediatrics, Rohilkhand medical college, Pilibhit bypass road, Pawan vihar, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  8057383699  
Fax    
Email  dr.plr21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devesh Agrawal 
Designation  Junior resident 
Affiliation  Rohilkhand Medical College 
Address  3012, Department of pediatrics, Rohilkhand medical college, Pilibhit bypass road, Pawan vihar, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  7011167866  
Fax    
Email  DEBUDEVESH2000@GMAIL.COM  
 
Source of Monetary or Material Support  
3012, Department of pediatrics, Rohilkhand medical college, Pilibhit bypass road, Pawan vihar, Bareilly, Uttar Pradesh, India 
 
Primary Sponsor  
Name  DR DEVESH AGRAWAL 
Address  3012, Department of pediatrics, Rohilkhand medical college, Pilibhit bypass road, Pawan vihar, Bareilly, Uttar Pradesh, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Devesh Agrawal  Rohilkhand medical college  3012, Department of pediatrics, Rohilkhand medical college, Pilibhit bypass road, Pawan vihar, Bareilly
Bareilly
UTTAR PRADESH 
7011167866

DEBUDEVESH2000@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, UP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  20.00 Day(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  Preterm babies
Neonates born with Gross Congenital deformities
Patient’s attendant who will not give informed consents.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical and antenatal profile in Late Pre-Term and Term neonate.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the clinical profile of Late pre-term and Term Neonate.
To study the antenatal risk factors in Late pre-term with Term neonate.
 
AT DISCHARGE 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 Problems Inadequate 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.

 
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