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CTRI Number  CTRI/2023/11/060341 [Registered on: 29/11/2023] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Benefit of Mouth Exercises Given to Premature Babies to Achieve Breastfeeding  
Scientific Title of Study   Influence of the Premature Infant Oral Motor Intervention (PIOMI) on Breastfeeding  
Trial Acronym  PIOMI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ferzeen Mody 
Designation  Post graduate student in pediatric physiotherapy  
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Physiotherapy, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal
-
Udupi
KARNATAKA
576104
India 
Phone  9082950826  
Fax  -  
Email  ferzeen.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhamini Krishna Rao  
Designation  Professor, Department of Physiotherapy, MCHP, MAHE, Manipal 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Physiotherapy, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal
-
Udupi
KARNATAKA
576104
India 
Phone  8660644145  
Fax  -  
Email  bhamini.kr@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mrs Deepalaxmi Poojary  
Designation  Assistant Professor Department of Physiotherapy, MCHP, MAHE, Manipal 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Physiotherapy, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal
-
Udupi
KARNATAKA
576104
India 
Phone  8971188465  
Fax  -  
Email  deepa.poojary@manipal.edu  
 
Source of Monetary or Material Support  
Department of physiotherapy, Kasturba Hospital, Room no 103, Manipal Academy of Higher Education (MAHE), Manipal 
 
Primary Sponsor  
Name  Ferzeen Mody  
Address  Department of Physiotherapy, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal 
Type of Sponsor  Other [self] 
 
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 Bhamini Krishna Rao  Manipal College of Health Professions   Department of physiotherapy, Kasturba Hospital, Room no 103, Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA 
8660644145
-
bhamini.kr@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Premature Infant Oral Motor Intervention (PIOMI)   PIOMI is a 5 minute structured oral motor intervention specifically designed for stable preterm infants developed by Dr Brenda Lessen Knoll which includes cheek stretch, lip roll, lip curl, midblade tongue pressure, lateral tongue pressure, gum massage and non nutritive sucking 
Comparator Agent  supervised breastfeeding   the infants referred for breastfeeding will be provided breastfeeding support from the nursing staff which is the routine practice  
 
Inclusion Criteria  
Age From  32.00 Day(s)
Age To  40.00 Day(s)
Gender  Both 
Details  stable preterm infants, aged more than 32 weeks of gestation, referred for oromotor stimulation by the co-investigator (neonatologist), in the step down unit of the department of neonatology 
 
ExclusionCriteria 
Details  preterm infants who have any congenital or genetic disorders which will not allow them to breastfeed in the near future; infants with necrotising enterocolitis, brain injury, cardiac complications or any illness; infants requiring assistive ventilation and infants receiving oxygen via high flow nasal cannula; mothers unable to breastfeed due to breast engorgement, poor milk flow, inverted nipple or any other complications. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
scores on the Early Feeding Skills Assessment Scale  baseline, day on which 1 direct breastfeed and 4 direct breastfeeds have been attained 
 
Secondary Outcome  
Outcome  TimePoints 
days taken to achieve 1 & 4 direct breastfeeding sessions, weight & age at which one & four successful direct breastfeeds were attained  baseline, days at which one & four successful direct breastfeeds are achieved 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   05/12/2023 
Date of Study Completion (India) 22/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/06/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Preterm infants will be recruited from the Neonatal Intensive Care Unit (step down unit) after receiving referral for oromotor intervention or breastfeeding from the treating physician. Once referral is obtained the infant’s caregivers will be contacted and provided with the patient information sheet and consent form, along with a detailed explanation of the study. After consent is obtained from the primary caregiver, the infant will be recruited in the study. Randomization will not be attempted as it is a quasi experimental study and it is not feasible to randomize. Infants referred for oromotor stimulation will be part of the intervention group and the ones referred for breastfeeding will be part of the control group. The demographic data will be collected and pre intervention data (EFS) will be administered by the secondary investigator who will be blinded to reduce bias. The control group will receive standard care (breastfeeding support given by the nursing staff) and the intervention group will receive PIOMI (a structured intervention specifically designed for stable preterm infants developed by Brenda Lessen Knoll which includes cheek stretch, lip roll, lip curl, midblade tongue pressure, lateral tongue pressure, gum massage and non nutritive sucking) from the primary investigator. Infants in both groups may be breastfeeding as well as on formula feeds, however, the infant must be able to tolerate at least one breastfeeding trial in a day. Both groups will be assessed till they achieve 4 successful breastfeeding attempts in a day. The Early Feeding Skills Assessment Scale (EFS) will be administered every alternate day till the infant is able to breastfeed 4 times a day successfully. Once the infant can breastfeed 4 times a day, the intervention will then be stopped and the post intervention EFS score will be recorded by the secondary investigator for the intervention group. Once the infants in the control group achieve 4 direct breastfeeding attempts their EFS scores will be assessed and recorded as well. The outcomes measured will be, scores on the EFS and the days taken to achieve 1 and 4 successful direct breastfeeds. The pre-intervention and post-intervention EFS scores will tell us about the effectiveness of the intervention (PIOMI). This process may last from a few days to weeks depending on the infant’s response.

 
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