| CTRI Number |
CTRI/2017/07/009006 [Registered on: 10/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [kangaroo mother care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to study the effect of kangaroo mother care (KMC) on duration of phototherapy in neonatal jaundice |
|
Scientific Title of Study
|
To Study the Effect of Kangaroo Mother Care on Duration of Phototherapy in Neonatal Jaundice; A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apoorva Chandil |
| Designation |
DNB Pediatric medicine student |
| Affiliation |
Chacha Nehru bal Chikitsalya |
| Address |
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031
New Delhi
DELHI
110031
India |
| Phone |
8375846683 |
| Fax |
|
| Email |
apoorvachandil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Jajoo |
| Designation |
associate professor ( guide) |
| Affiliation |
Chacha Nehru bal Chikitsalya |
| Address |
Department of pediatrics
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031
New Delhi
DELHI
110031
India |
| Phone |
9643308217 |
| Fax |
|
| Email |
mamtajajoo123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva Chandil |
| Designation |
DNB Pediatric medicine student |
| Affiliation |
Chacha Nehru bal Chikitsalya |
| Address |
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031
New Delhi
DELHI
110031
India |
| Phone |
8375846683 |
| Fax |
|
| Email |
apoorvachandil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031 |
|
|
Primary Sponsor
|
| Name |
Chacha Nehru Bal Chikitsalya |
| Address |
Chacha Nehru Bal Chikitsalya Geeta colony
Delhi 110031 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Apoorva Chandil |
Chacha Nehru Bal Chikitsalaya |
Neonatal Intensive Care Unit
pediatric medicine Chacha Nehru Bal Chikitsalaya
Geeta Colony 110031
New Delhi
DELHI |
8375846683
apoorvachandil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College And Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
hemodynamically stable neonates requiring phototherapy for neonatal jaundice, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional care |
neonates allocated to conventional care will receive conventional phototherapy 24 hours a day.serum bilirubin and transcutaneous bilirubin , daily weight gain , temperature every eight hourly will be monitered, phototherapy will be stopped when serum bilirubin falls below the threshold required for phototherapy. |
| Intervention |
Kangaroo Mother Care (KMC) |
neonates allocated to Kangaroo Mother Care (KMC) will receive phototherapy with the same settings along with one hour of KMC eight hourly.During kmc mother or any other caregiver will be provided goggles. She or he will be sitting in a chair providing KMC to the neonate while the phototherapy panel is held against the back of the baby In a shielded area with room temperature maintenance of 25 to 30 degree centigrade .serum bilirubin and transcutaneous bilirubin,daily weight gain, temperature before, during and after KMC will be monitered. phototherapy will be stopped when serum bilirubin falls below the threshold required for phototherapy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1.hemodynamically stable neonates admitted in NICU
2.gestational age 30 to 40 weeks
3.weighing more than 1000 but less than 2000 gram
4.requiring phototherapy as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age |
|
| ExclusionCriteria |
| Details |
1.Patient with major congenital malformations
2.Unstable patients on CPAP (Continuous Positive Airway Pressure) or on ventilator or requiring ionotropes.
3.Patient requiring exchange transfusion as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age .
4.Patient presenting with jaundice in first 24 hours of life with rate of rise of bilirubin > 5 mg/ dl/day.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of phototherapy required |
duration of phototherapy required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rate of fall in serum bilirubin |
rate of fall in serum bilirubin during phototherapy required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age |
| weight gain per day |
weight gain per day during phototherapy required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age |
| temperature maintenance |
temperature is measured eight hourly or before , duringand after KMC till phototherapy is required as per AAP guidelines 2004 for newborns more than 35 weeks of gestational age and as per criteria laid down by Maisels et al ( Jour Perinatol 2012)for newborns less than 35 weeks of gestational age |
| hospital stay |
discharge of patient from NICU |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Kangaroo Mother Care [KMC] consists of skin to skin contact between mother and infant in a vertical position (kangaroo position). It helps in preventing hypothermia, stabilizes physiological parameters, significantly increases breast milk production, improves weight gain and helps in early discharge. Phototherapy is the mainstay of treating hyperbilirubinemia in neonates. During phototherapy the neonate is kept naked under the light in a cot and is taken out only for breastfeeding. Hence during phototherapy there is lack of contact between mother and baby which deprives the baby from the benefits of KMC. This study proposes to analyze the effect of intermittent KMC in neonatal jaundice. By giving phototherapy along with KMC in one group and only photoherapy in another, this study will show if KMC is effective in reducing the duration of phototherapy required in neonatal jaundice.
|