| CTRI Number |
CTRI/2023/08/056386 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [prefeeding stimulation] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of nurse led combined modalities on bonding, anxiety, knowledge and practice
towards the care of preterms among mothers and on the physiological parameters of their
neonates |
|
Scientific Title of Study
|
Effectiveness of nurse led combined modalities on bonding, anxiety, knowledge and practice
towards the care of preterms among mothers and on the physiological parameters of their
neonates admitted to neonatal intensive care unit at a selected tertiary care hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharin Neetal Dsouza |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College
Yenepoya university
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09972413432 |
| Fax |
|
| Email |
dsouzasharin83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Reshma Aranha |
| Designation |
HOD |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College
yenepoya university
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845389735 |
| Fax |
|
| Email |
priyaresh.menezes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Benazeera |
| Designation |
Assistant Professor |
| Affiliation |
YENEPOYA NURSING COLLEGE |
| Address |
enepoya Nursing College
yenepoya university
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844910806 |
| Fax |
|
| Email |
benzi407@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study will be conducted in Yenepoya Medical College Hospital, Dearalakatte |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Viji Prasad |
Yenepoya medical college hospital |
yenepoya university
deralakatte
Dakshina Kannada
KARNATAKA |
8762747306
vijiprsd454@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committe 1 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
postnatal mothers and neonates |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
PIOMI
NURSE LED COMBINED MODALITIES |
Premature infant oral motor intervention (PIOMI) provided by the investigator to
the preterm neonate for a duration of 5min. It is a focused 8-step therapy that is administered
to the preterm neonate using all aseptic precautions with gloved fingers that are designed to
assist the preterm infants functional response to pressure and movements of the lips, jaws,
and tongue. It will be performed in the following order: stimulation of the cheeks (twice for
30 seconds), lip stimulation (once for 30 seconds), pursing the lips (once for 30 seconds),
stimulation of the gums (twice for 30 seconds), stimulation of thelateral sides of the tongue
and sides of the cheek (twice for 15 seconds), stimulation of themedial septum of the tongue
and palate (twice for 30 seconds), and nonnutritive sucking with a gloved finger (2 minutes).
Kangaroo mother care (KMC) :t is the practice of providing early, continuous, prolonged
skin to skin contact between mother and her baby.32
In this study it refers to the provision of direct skin to skin contact of baby and mother.
The baby wearing only the nappy/pampers is placed on the bare chest of the mother in
between the breasts where both mother and baby come to direct skin to skin contact,. Baby is
maintained in this position by placing a clean cloth wrapped round the baby and the mother.
The mother will be providing the KMC under the supervision of investigator for 20minutes.
ï‚· Total time taken for administration of NLCM for preterm neonate is 25min. Investigator will
be providing 2 session/day for 7 days.
Video assisted teaching on care of preterm neonate including Palada feeding, breast
feeding, prevention of hypothermia, care of skin, eyes, umbilical cord, prevention from
infection, mummification etc. This teaching is done for 15minutes.
ï‚· Demonstration of various aspects of care of preterm neonate including Kangaroo
mother care and routine care of neonates which include hand washing, wearing gloves,
wearing gown to enter NICU, holding the baby, feeding technique, burping, mummification.
The demonstration session will be for 20minutes, after the demonstration investigator will
insure that mother does the return demonstration and gains the skill.
ï‚· Interactive session this will be given after video teaching and demonstration to the mothers.
Here mother will be encouraged to ask questions or any doubts regarding care of preterm babies
and investigator will be clarifying the doubts. This teaching is done for 10minutes. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
20.00 Day(s) |
| Gender |
Both |
| Details |
a) Preterm neonates
1.Born between 30-35weeks of gestation
2.Admitted in NICU
3.Receiving NG tube feeding
4.Hemodynamically stable and expected to be in NICU for 7 days after the initiation of
intervention
5.Having no anatomical defects such as cleft palate, cleft lip, and congenital disorder
according to the records that doesn’t permit them to undergo nurse led combined
modality.
6.Planning to initiate oral feeding
b) Mothers
1.Admitted in postnatal ward
2.Permitted to visit NICU regularly and involve in care of preterm neonates. |
|
| ExclusionCriteria |
| Details |
Preterm neonates who are
1.Critically ill
ï‚·2.On ventilator
b) Mothers
1. Having postnatal complications which hinders her to participate in NLCM
2.Physically and mentally not stable / challenged |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
feeding progression
early discharge
weight gain |
Result will be seen in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| early discharge |
7-14days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/08/2023 |
| 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="2"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to find the effectiveness of prefeeding stimulation of preterm neonates and along with this intervention will be provide for mothers regarding newbron care. This involves vulnerable population, so investigator want to avoid duplication of her study so want to register study title in CTRI
|