| CTRI Number |
CTRI/2024/08/072326 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The knowledge of kangaroo mother care among mothers of moderate and late preterm neonates and its association with infant weight gain. |
|
Scientific Title of Study
|
The association of the knowledge of kangaroo mother care among mothers of moderate and late preterm neonates and infant weight gain- A single blinded parallel randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC KMC MLR 05/2023/201 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TV Sai Krupa |
| Designation |
paediatrics junior resident |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Paediatrics department, Kasturba Medical College, Light house hill road, Mangalore, Dakshina kannada,
Karnataka, 575001, India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8919792183 |
| Fax |
|
| Email |
krupa.reddy95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran N Baliga |
| Designation |
Paediatrics Associate Professor |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Paediatrics department, Kasturba medical college, Light house hill road, Mangalore, Dakshina kannada,
Karnataka, 575001, Indi
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9886198991 |
| Fax |
|
| Email |
baligakiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TV Sai Krupa |
| Designation |
Paediatrics Junior resident |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, light house hill road, Mangalore, Dakshina kannada,
Karnataka, 575001, India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8919792183 |
| Fax |
|
| Email |
krupa.reddy95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ladygoschen hospital, maidan road,hampankatta,mangalore-575001,karnataka. |
|
|
Primary Sponsor
|
| Name |
TV SAI KRUPA |
| Address |
Kasturba Medical College, Light house hill road, Mangalore, Dakshina kannada,
Karnataka, 575001, India |
| Type of Sponsor |
Other [self] |
|
|
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 TV Sai Krupa |
Government Lady Goschen Hospital |
Postnatal Wards,5th floor, Maidan Road, Hampankatta, Mangalore-575001, Karnataka.
Dakshina Kannada
KARNATAKA |
8919792183
krupa.reddy95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm babies and their mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
standard protocol of care plus education by primatory investigator using flipcharts. |
Intervention group will be educated by principal investigator where the mother will be explained about KMC in detail using flip charts. These sessions will be conducted as one to one training sessions and all the queries of the participants will be cleared. After 48 hrs, the assessment of knowledge, attitude, and practice of KMC will be tested by a validated questionnaire. If post assessment score is less than 60%, the mother will be reinforced on the factors the mother was lacking. The next day, the Kangaroo mother care skills of these mothers will be assessed by a trained maternity nurse or social health worker who is blind to this study. All the mothers will be enquired about adherence to KMC during the follow up visits at 6 weeks and 6 months of age. |
| Comparator Agent |
standard protocol of care where the explanation will be given as per hospital protocol. |
The participants in the Control group will have standard protocol of explanation about KMC as per hospital protocols.After 48 hrs, assessment of mother’s knowledge, attitude, and practice about KMC, will be evaluated by a validated questionnaire. The next day, the Kangaroo mother care skills of these mothers will be assessed by a trained maternity nurse or social health worker who is blind to this study. All the mothers will be enquired about adherence to KMC during the follow up visits at 6 weeks and 6 months of age. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Both |
| Details |
1. Stable Moderate and Late Preterm neonates with gestational age more than 32 weeks and their mothers.
2. Mothers who are willing to give exclusive breastmilk feeds for six months.
3. Neonates who are on exclusive breastmilk with calorie consumption of 150-170 kcal/kg/day.
|
|
| ExclusionCriteria |
| Details |
1. Haemodynamically unstable neonates who unfit for KMC during study period.
2. Neonates who are admitted in NICU for more than 48 hours.
3. Mothers who are unable to give KMC as they are critically ill.
4. Mothers with lactational failure.
5. Mothers who are unable to comply with follow up.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The association of the knowledge of Kangaroo Mother Care among mothers of moderate and late preterm and weight gain of the preterm infant. |
1. within 48 hours
2. at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the knowledge of Kangaroo Mother Care among mothers of preterm neonates.
2. To compare the knowledge retention about Kangaroo mother Care in mothers of preterm neonates between the educational intervention group and control group.
|
1. Within 48 hrs
2. at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2024 |
| 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 Yet Recruiting |
| 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
|
A Single blinded parallel- randomized controlled trial will be conducted in Government Ladygoschen Hospital in Mangalore.The study participants satisfying the inclusion criteria will be approached, and the nature and objectives of the study will be explained in a language understood by them. After obtaining the consent, the subjects (mothers) will be divided in to two groups.Each group will have two arms and block randomization will be used to divide the group. Block size of 6 will be used, with the possibility of 56 permutations and combinations. To reach the sample size of 86, a total of 15 such blocks will be used in a randomly generated sequence so that an equal number of participants will be allocated in both the groups. For example:(ABABAB/AABBAB/ABBABA/BBBAAA and so forth) For a block size of 6, the sequence will be generated. Opaque envelope method will then be used for concealment of allocation into the intervention groups. (i) Intervention Group: The participants in the Intervention group will undergo the standard protocol of care where the explanation about KMC will be given as per the hospital protocol. This group of mothers will also be educated by principal investigator where the mother will be explained about KMC in detail in a language understood by them, using flipcharts, in a 30- minute training sessions. These sessions will be conducted as one to one training sessions and all the queries of the participants will be cleared. After 48 hrs, the assessment of knowledge, attitude, and practice of KMC will be tested by a validated questionnaire. If post assessment score is less than 60%, the mother will be reinforced on the factors the mother was lacking. The next day, the Kangaroo mother care skills of these mothers will be assessed by a trained maternity nurse or social health worker who is blind to this study. All the mothers will be enquired about adherence to KMC during the follow up visits. (ii) Control Group: The participants in the Control group will have standard protocol of explanation about KMC as per hospital protocols. After 48 hrs, assessment of mother’s knowledge, attitude, and practice about KMC, will be evaluated by a validated questionnaire. The next day, the Kangaroo mother care skills of these mothers will be assessed by a trained maternity nurse or social health worker who is blind to this study. All the mothers will be enquired about adherence to KMC during the follow up visits.Anthropometry of all neonates will be taken in the following manner and at the following intervals: (i) Weight: All neonates will be weighed on electronic baby weighing scale (SAMSO) with sensitivity of 10 grams and will be plotted on INTERGROWTH 21 Charts at the following intervals: - Immediately after birth, - On the day of initiation of KMC - At discharge - At follow up at 2 weeks and 6 weeks post discharge (ii) Length: Length of all neonates will be measured using Infantometer (MCP Infantometer) on the day of delivery and on the day of initiation of KMC and these will be plotted on INTERGROWTH 21 Charts at the following intervals: - Immediately after birth, - At discharge - At follow up at 2 weeks and 6 weeks post discharge (i) Head circumference: Head circumference of all neonates will be measured by using a non-Stretchable measuring tape and these will be plotted on INTERGROWTH 21 Charts at the following intervals: - After 24 hours of delivery - At discharge - At follow up at 2 weeks and 6 weeks post discharge
|