| CTRI Number |
CTRI/2022/07/043951 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Feeding skills in Premature Neonates |
|
Scientific Title of Study
|
Assessment of Oral Feeding Readiness in Preterm Neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranavari Bhagya Sri Bai |
| Designation |
Post graduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical Sciences and Hospital
SDM College of Physiotherapy Manjushree Nagar Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
7981794991 |
| Fax |
08362462253 |
| Email |
bhagyaranavari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranavari Bhagya Sri Bai |
| Designation |
Post graduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical Sciences and Hospital
SDM College of Physiotherapy Manjushree Nagar Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
7981794991 |
| Fax |
08362462253 |
| Email |
bhagyaranavari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti S Jeevannavar |
| Designation |
Professor and PG Guide |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical Sciences and Hospital
SDM College of Physiotherapy Manjushree Nagar Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
08362462253 |
| Email |
drjyotisj@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad 580009 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Ranavari Bhagya Sri Bai |
| Address |
SDM College of Medical Sciences and Hospital
SDM College of Physiotherapy Manjushree Nagar
Sattur
Dharwad 580009
Karnataka 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 |
| Ranavari Bhagyasri Bai |
SDM College of Medical Sciences and Hospital |
Paediatric Physiotherapy Department OPD Number 13 SDM College of Medical Sciences and Hospital
SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad 580009 Karnataka India
Dharwad
KARNATAKA |
7981794991
08362462253
bhagyaranavari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Permission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm neonates
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates of 28 – 37 weeks of gestational age
2. Neonates who are clinically stable
3. Neonates of either gender |
|
| ExclusionCriteria |
| Details |
1. Neonates with congenital anomalies like cleft lip, cleft palate, congenital cardiac
conditions (ASD, VSD).
2. Neonates with facial deformities
3. Neonates on mechanical ventilation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PRETERM ORAL FEEDING READINESS ASSESSMENT SCALE (POFRAS) |
One Time Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2022 |
| Date of Study Completion (India) |
10/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Preterm neonate is defined as infant of 28 days old, who is born on or before 37th week (259 days) of pregnancy, calculated from the first day of the last menstrual period. The most important factors influencing preterm birth are intrauterine haemorrhage, multiple pregnancies, pre eclampsia, fetal disorders etc..,. Globally, the neonatal mortality rate is high and the major proportion of this is increased by preterm neonatal deaths as they are vulnerable because of low birth weight, gestational age, asphyxia, hypothermia, hypoglycemia, infections and NEC. Breast feeding promotes the development, prevents malnutrition and mortality. Neonatal diet is important to prevent NEC. The admission of neonate in NICU is because of the above mentioned causes where the neonates are managed through mechanical ventilation, oxygen support, endotracheal tube and tube feeding. As prolonged artificial ventilation and tube feeding influences the feeding abilities of neonate. The delay of primitive reflexes and development of feeding skills in neonate lead to infection, NEC, failure to thrive. Oral feeding readiness is one of the discharge criterion of NICU, post natal growth of preterm neonates is a result of interaction of increased respiratory work, morbidity, nutrition and immaturity of gastrointestinal tract. According to recent studies the prevalence of oral feeding difficulties is more in preterm neonate as they present with gag reflex, choking, aspiration, incoordination of suck swallow breath and these influence the increases the length of hospital stay along with social and economic SUMMARY Page 51 burden. So, the early evaluation and intervention of preterm neonates to manage oral feeding related issues is more concerned. The aim of the study is assess the oral feeding readiness in preterm neonates. Preterm neonates born and admitted in NICU and OBG wards of SDM college of health sciences and hospital were screened for the inclusion criteria and exclusion criteria, obtained consent from parents and were assessed for the oral feeding readiness on POFRAS scale and the scores were analyzed. The analysis of the study reported that there is significant difference in the birth weight and POFRAS score of very preterm and moderate to late preterm neonates. There is statistical significant positive correlation of POFRAS score with GA, birth weight in baby boy and baby girls. There was statistically significant difference in oral pre feeing readiness in baby girls than baby boys. The study concluded that the gestational age and birth weight had significant correlation and influence on oral pre feeding readiness in preterm neonates. The presence of pre feeding readiness is significantly higher in female than the male preterm neonates.
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