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CTRI Number  CTRI/2024/03/063666 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Premature Infant Oro Motor Intervention to achieve better breast feeding behavior in preterm less than 32 weeks- a Randomised control trial 
Scientific Title of Study   Role of Premature Infant Oro Motor Intervention to achieve better breast feeding behavior in preterm less than 32 weeks -a randomised control trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anand kumar G 
Designation  dm neonatology resident 
Affiliation  saveetha medical college hospital 
Address  No 151, NICU, Department of Neonatology,1st floor,saveetha medical college hospital, chennai

Kancheepuram
TAMIL NADU
600124
India 
Phone  9629240204  
Fax    
Email  ggdranand@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr Kumutha J 
Designation  Dean, Prof, HOD, Department of neonatology 
Affiliation  saveetha medical college hospital 
Address  No 151, NICU, Department of Neonatology,1st floor,saveetha medical college hospital, chennai

Kancheepuram
TAMIL NADU
600124
India 
Phone  9444023733  
Fax    
Email  drkumutha@gmail.com  
 
Details of Contact Person
Public Query  
Name  dr Kumutha J 
Designation  Dean, Prof, HOD, Department of neonatology 
Affiliation  saveetha medical college hospital 
Address  No 151, NICU, Department of Neonatology,1st floor,saveetha medical college hospital, chennai

Kancheepuram
TAMIL NADU
600124
India 
Phone  9444023733  
Fax    
Email  drkumutha@gmail.com  
 
Source of Monetary or Material Support  
nil 
Saveetha Medical College Hospital, Thandalam , Chennai 
 
Primary Sponsor  
Name  Saveetha Medical College Hospital  
Address  no 151, NICU, 1st floor, saveetha medical college hospital, Chennai, 600124 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr Anand Kumar  Saveetha Medical College Hospital  no 151, nicu, DEPARTMENT OF NEONATOLOGY, 1 ST floor,Saveetha Medical College Hospital, Thandalam , Chennai
Kancheepuram
TAMIL NADU 		 9629240204

ggdranand@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College Hospital Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P038||Newborn affected by other specified complications of labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  developmental supportive care  Non nutritive sucking, Kangaroo mother care, palladai feeds 
Intervention  Premature Infant Oromotor Intervention  • Eligible babies will be randomized after obtaining written informed consent from parents. They will receive either PIOMI along with standard care in the intervention group and developmental supportive care alone in the control group. • The principal investigator will undergo training from the PIOMI designer Dr Brendon Lessen . He will get the certificate after the training. The principal investigator will also undergo a training for this Oro-motor intervention in the department of occupational therapy prior to the start of the study regarding correct order of steps with correct technique and time spent at each step. The principal investigator then will teach the mother about the technique. Mother will be trained to do PIOMI several times till she is confident. • Infants randomized to PIOMI group will be subjected to 5 minutes of PIOMI intervention three times daily for consecutive days. This will be done for 2 weeks. • The principal investigator would perform PIOMI once per day on babies 26-31 wks. Twice per day for 32 weeks of corrected gestational age. After approval from the principal investigator the mother can perform PIOMI under observation of the principal investigator. • After 2 weeks the breastfeeding behavior in these preterm babies will be assessed using PIBBS questionnaire. The occupational therapist who is blinded to the study will assess the PIBBS questionnaire for 3 consecutive days. • The procedure will be done using all aseptic precautions with gloved fingers. All mothers will be trained on proper hand hygiene. Regular controls of the protocol adherence will be checked to assure reliability of the administrator.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  2.00 Month(s)
Gender  Both 
Details  Preterm 29-32 weeks ,
48 hrs after hemodynamic stability 
 
ExclusionCriteria 
Details  1. Congenital malformations including cleft lip and cleft palate
2. Chromosomal anomalies
3. Requires subsequent mechanical ventilation
4. Intraventricular haemorrhage
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study breastfeeding behaviour after intervention using PIBBS (PRETERM INFANT BREASTFEEDING BEHAVIOR SCALE) scale  To study breastfeeding behaviour after intervention using PIBBS (PRETERM INFANT BREASTFEEDING BEHAVIOR SCALE) scale. after 14days of intervention or no treatment (in control group)i.e on day 15, 16,17 of recruitment. average of the 3 PIBBS score will be taken 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the length of hospital stay  time taken to reach 2000gm of weight for discharge 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   Phase 3 
Date of First Enrollment (India)   15/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   PIOMI wil be given for preterm babies 48 hrs after they are hemodynamically stable. PIOMI will be given for 26 babies for 14 days. In 26 babies in control group  no intervention will be given. After 14 days in each group, breast feeding behavior will be assessed by PIBBS (Preterm Infant Breastfeeding behavior scale) scale. Both the group will be compared for the effectiveness of breastfeeding using the PIBBS scale.  
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