| 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
|
|
|
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
|
|
|
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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