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
|
|
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
|
|
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.
|