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CTRI Number  CTRI/2019/01/017125 [Registered on: 17/01/2019] Trial Registered Prospectively
Last Modified On: 05/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [different regimen of intravenous fluid administration in babies with TTNB requirinf CPAP]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing liberal versus restricted fluid administration in newborn with respiratory distress after birth. 
Scientific Title of Study   A Randomized controlled trial comparing restricted vs standard fluid administration in late preterm and term newborn with transient tachypnea of newborn requiring respiratory support 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Somnath Pal 
Designation  Post doctoral senior resident 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Institute of Post Graduate Medical Education and Research,Kolkata, Department of Neonatology, Division - Neonatal Intensive Care Unit, Room no 1, 244,AJC Bose Road, P.S- Bhowanipur, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9903457386  
Fax    
Email  somnathpal1983@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Somnath Pal 
Designation  Post doctoral senior resident 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Institute of Post Graduate Medical Education and Research, Kolkata, Department of Neonatology, Division - Neonatal Intensive Care Unit, Room no-1, 244,AJC Bose Road,P.S- Bhowanipur,Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9903457386  
Fax    
Email  somnathpal1983@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Somnath Pal 
Designation  Post doctoral senior resident 
Affiliation  Institute of Post Graduate Medical Education and Research 
Address  Institute of Post Graduate Medical Education and Research, Kolkata, Department of Neonatology, Division - Neonatal Intensive Care Unit, Room no 1, 244 , AJC Bose Road, P.S- Bhowanipur, kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9903457386  
Fax    
Email  somnathpal1983@gmail.com  
 
Source of Monetary or Material Support  
Institute of Post Graduate Medical education and Research, Department of Neonatology, 244,AJC Bose road, P.S-Bhowanipur, Kolkata-700019 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research Department of Neonatology 
Address  244 AJC Bose road, P.S- Bhowanipur, kolkata-700020 
Type of Sponsor  Government medical college 
 
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 
Somnath pal  Institute of Post Graduate Medical Education and Research, kolkata  244,AJC Bose Road,P.S-Bhowanipore, Kolkata-700020 Department of Neonatology Division - Neonatal Intensive Care Unit, Room no 1,
Kolkata
WEST BENGAL 
9903457386

somnathpal1983@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Advisory Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P221||Transient tachypnea of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  intravenous fluid   late preterm and term newborn with TTNB requiring CPAP received 60 , 80 and 100 ml/kg of total fluid ( including both parenteral and enteral route ) on day 1,2 and 3 respectively, 
Intervention  intravenous fluid   late preterm and term newborn with TTNB requiring CPAP recieved 40 , 60 and 80 ml/kg of total fluid ) on day 1,2 and 3 respectively 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  1. Inborn babies from 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support
2. Outborn babies presenting within 6 hrs of life of gestational age 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support
3. Parents of eligible babies giving consent for participation
 
 
ExclusionCriteria 
Details  1. Presence of air leak
2. Presence of congenital anomalies
3. Diagnosis of other causes of respiratory distress ( MAS, RDS, suspected sepsis, Surgical causes)
4. Perinatal asphyxia 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of CPAP support in both the groups of babies with TTNB requiring CPAP   72 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
•Incidence of CPAP failure in newborn with TTNB requiring CPAP in standard fluid management and restricted fluid manageent group.  72 hrs 
Duration of NICU stay in both the groups of babies with TTNB requiring CPAP  7 days 
Incidence of neonatal morbidities ( Hyperbilirubinemia, Hypoglycemia, dehydration )in both the groups of babies with TTNB requiring CPAP  72 hrs 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 17/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Sardar S, Pal S, Mishra R. A randomized controlled trial of restricted versus standard fluid management in late preterm and term infants with transient tachypnea of the newborn [published online ahead of print, 2020 May 20]. J Neonatal Perinatal Med. 2020;10.3233/NPM-190400. doi:10.3233/NPM-190400 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

BACKGROUND: Transient tachypnea of the newborn(TTNB) is the most common respiratory morbidity in late preterm and term babies and is pathophysiologically related to delayed lung fluid clearance after birth. Mimicking low physiological fluid intake in the initial period of life may accelerate the recovery from TTNB. In a randomized controlled trial, we compared the roles of restricted versus standard fluid management in babies with TTNB requiring respiratory support.


METHODS: This parallel group,non-blinded, stratified randomized controlled trial was conducted in a level III neonatal unit of eastern India. Late preterm and term babies with TTNB requiring continuous positive airway pressure (CPAP) were randomly allocated to standard and restricted fluid arms for the first 72 hours (hrs). Primary outcome was CPAP duration.


RESULTS: In total, 100 babies were enrolled in this study with 50 babies in each arm. CPAP duration was significantly less in the restricted arm (48[42, 54] hrs vs 54[48,72] hrs, p = 0.002). However, no difference was observed in the incidence of CPAP failure between the two arms. In the subgroup analysis, the benefit of reduced CPAP duration persisted in late preterm but not in term infants. However, the effect was not significant in the late preterm babies exposed to antenatal steroid.


CONCLUSION: This trial demonstrated the safety and effectiveness of restrictive fluid strategy in reducing CPAP duration in late preterm and term babies with TTNB. Late preterm babies, especially those not exposed to antenatal steroid were the most benefitted by this strategy.

 


 
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