| CTRI Number |
CTRI/2017/01/007716 [Registered on: 16/01/2017] Trial Registered Prospectively |
| Last Modified On: |
17/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [baby massage with oil] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Reduction of physiological jaundice in term babies with the help of baby massage |
|
Scientific Title of Study
|
Effectiveness of baby massage on Physiological Jaundice among neonates with phototherapy in a selected hospital, Mangaluru. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Mini O A |
| Designation |
PG student |
| Affiliation |
father muller college of nursing |
| Address |
superior
St Lukes Hospital
Shrirampur
Ahemednagar
Maharashtra
Father Muller College of nursing
Kanaknady
Mangalore
Ahmadnagar
MAHARASHTRA
413709
India |
| Phone |
8970605169 |
| Fax |
|
| Email |
antonymini@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Wilma S Noronha |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College Nursing |
| Address |
Father Muller College of nursing
Kanaknady
Mangalore
Father Muller College of nursing
Kanaknady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9481765777 |
| Fax |
|
| Email |
shaline_1975@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Bridget D Silva |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing. |
| Address |
Father Muller College of nursing
Kanaknady
Mangalore
Father Muller College of nursing
Kanaknady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9483705629 |
| Fax |
|
| Email |
bridgetbaludsilva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital
kankanady
Mangaluru |
|
|
Primary Sponsor
|
| Name |
Ms Mini O A |
| Address |
Superior
St Lukes Hospital
Shrirampur
Ahemednagar
Maharashtra |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Ms Seema S Chavan |
Father Muller Medical College HospitalNe |
Neonatal Intensive Care Unit
Father Muller Medical College Hospital
Dakshina Kannada
KARNATAKA |
9480536882
seemachavan23@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infant with physiological jaundice, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilirubin Level |
study it refers to the treatment given to the neonates with physiological jaundice, whose serum bilirubin level is more than 5mg/dl by using single, double or triple surface phototherapy unit with fluorescent blue or white light |
| Intervention |
Phototherapy |
It is a form of treatment that converts bilirubin into photoisomers that can bypass the conjugating system of the liver and be excreted in the bile or urine without further metabolism |
| Intervention |
Special Baby Massage |
In this study it refers to the application of coconut oil on the palm of the investigator & massaging the neonate, in a smooth, gentle, stroking manner starting from the face, chest, arms & hands, abdomen, feet & back for 10 minutes daily for consequent three days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Healthy term neonates whose bilirubin level is more than 5mg/dl
Neonates with the onset of jaundice after 24 hours & before 7th day of birth.
Neonates born with 37 weeks of gestation & above
Neonates birth weight is more than 2000grams
Neonates with APGAR of 8-10 after 5minutes of birth
Neonates receiving phototherapy for hyperbilirubinemia.
|
|
| ExclusionCriteria |
| Details |
Pre term neonates.
Rh & ABO incompatibility
Major congenital anomalies & infections
Hyperbilirubinemia requiring exchange blood transfusion
Glucose 6-phosphate dehydrogenase deficiency
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of Bilirubin leve
Reduced Hospital stay
Reduced financial |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
constraints on the parents
Increased maternal bonding |
4days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/02/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet Publishing |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess the level of physiological jaundice in experimental and control group before baby massage by checking the physiological parameters To evaluate the effectiveness of baby massage on physiological jaundice by comparing experimental and control group to find the association of physiological jaundice with selected demographic variables |