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CTRI Number  CTRI/2020/03/024061 [Registered on: 19/03/2020] Trial Registered Prospectively
Last Modified On: 14/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oromotor stimulation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the effect of oral massage therapy on premature babies feeding ability, weight gain and duration of hospital stay during hospital stay and in early infancy. 
Scientific Title of Study
Modification(s)  
Effect of pre-feeding oromotor stimulation on feeding performance, weight gain and duration of hospital stay during hospitalization and early infancy among preterm neonates admitted at selected Special newborn care units of Kolkata: a randomized controlled trial. 
Trial Acronym  ROMS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suvashri Sasmal 
Designation  Ph.D. Nursing student 
Affiliation  IPGME&R and SSKM Hospital 
Address  SNCU, Depatment of Neonatology, IPGME&R
SNCU, Department of Neonatology,IPGME&R
Kolkata
WEST BENGAL
700020
India 
Phone  919831277932  
Fax    
Email  suvashri.sasmal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bijan Saha 
Designation  Associate Professor 
Affiliation  IPGME&R and SSKM Hospital 
Address  Department of Neonatology, IPGME&R and SSKM Hospital
Department of Neonatology, IPGME&R and SSKM Hospital
Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Asha P Shetty 
Designation  Professor cum Principal 
Affiliation  College of Nursing, AIIMS Bhubaneswar 
Address  College of Nursing, All India Institute of Medical Sciences (AIIMS) Bhubaneswar, Post Dumuduma, Sijua, Khorda District, Bhubaneswar, Odisha, PIN: 751019

Khordha
ORISSA
751019
India 
Phone  9438884270  
Fax    
Email  nurs_asha@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
IPGME&R and SSKM Hospital, Kolkata 
 
Primary Sponsor  
Name  IPGMER and SSKM Hospital Kolkata 
Address  AJC Bose Road, Kolkta:700020 
Type of Sponsor  Research institution and hospital 
 
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 
Suvashri Sasmal  IPGME&R SSKM Hospital  Department of Neonatology Kolkata:700020
Kolkata
WEST BENGAL 
919831277932

suvashri.sasmal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight 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
Modification(s)  
Type  Name  Details 
Comparator Agent  No oromotor stimulation  Routine feeding and supporting care as per the unit protocol including Non- Nutritive Sucking (NNS) before each feed and Kangaroo Mother Care (KMC) 
Intervention  Prefeeding oromotor stimulation  Preterm neonates of treatment group will receive a five minutes pre-feeding oromotor stimulation of which 3 mins. consists of oral and perioral manual message and 2 mins is of non- nutritive sucking (NNS). It will be given 15-30 min prior to any two consecutive feedings each day for seven days consecutively. The preterm neonates of control group will receive similar intervention to keep the primary care givers, unit staffs blind folded. 
 
Inclusion Criteria
Modification(s)  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Inborn, preterms born between 26 0/7- 32 0/7 weeks
gestational age,
hemodynamically stable and receiving mother’s
milk as gavage feeds atleast 100ml/day
will be included. Mother as the primary caregiver at SNCU 
 
ExclusionCriteria 
Details  Neonates with medical complications like grade III or IV intraventricular hemorrhage, severe perinatal asphyxia, severe sepsis, NEC, congenital disease or malformation which might effect oral feeding progression will be excluded. The babies who kept NPO, deteriorated or became unstable during intervention period, babies whose mother are not the primary caregiver at SNCU will be excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Oral feeding performance will be measured by standardized tools,POFRAS (Preterm Oral Feeding Readiness Assessment Scale) score, Early feeding scale (EFS) score, mode of oral feeding at 1 month, 3 months and 6 months  POFRAS score on day 1, day 7, on the day of initiation of oral feeding, on the day of full oral feeding. EFS score on the day of full oral feeding and on the day of discharge. Oral feeding performance in early infancy i.e.mode of feeding will be recorded at corrected age of 1 months, 3months and 6
months. 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Weight gain during hospital stay and in early infancy

Duration of hospital stay 
Body weight related data will be taken from daily
record of the preterm on day 1, day 7, on the day
of initiation of oral feeding, on the day of full oral
feeding, at the time of discharge and at 1 month, 3 months and 6 months

Duration of hospitalization will be calculated from
the day of admission till the day of discharge 
 
Target Sample Size
Modification(s)  
Total Sample Size="130"
Sample Size from India="130" 
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)   02/10/2020 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Ever year, an estimated 15 million babies are born preterm and as per WHO data India tops the list of nations contributing sixty percent of these preterm birth. At around 32-34 weeks of gestation sucking swallowing and breathing coordination occurs though it can be affected by various factors which;leads to depressed oral reflexes and poor oral intake. As per AAP guidelines, independent oral feeding attainment is an important criteria for discharge of preterm babies and it has been found that breastfeeding rate among preterms varies from 49%-60% though Indian data in this regard is not available. Oromotor stimulation is a non invasive treatment which includes systematic way of massaging lips, gums, hard palate and stimulating tongue; can be provided even by the family members to facilitate oromotor coordination. Existing literature supports that oromotor stimulation can significantly improve the oral feeding performance of preterm babies. Thus this study has been attempted.

Research question:

- Does prefeeding oromotor stimulation make a difference in feeding performance and body weight of preterm neonates during hospitalization and in early infancy?

- Do prefeeding oromotor stimulation make any impact on duration of hospitalization?

Hypothesis

H1 There is a significant difference between the oral feeding performance during hospitalization and early infancy among treatment and control group at 0.05 level of significance.

H2 There is a significant difference of mean weight gain during hospitalization and early infancy among preterm neonates of treatment group and control group at 0.05 level of significance.

H3 There is a significant difference between mean duration of hospital stay among preterm neonates of treatmenr group and control group at 0.05 level of significance.

Method of data collection:

The preterm neonates will be allocated to treatment and control group by computer generated random randomization. Informed consent will be taken from primary caregivers and baseline data will be taken. Preterm neonates of experimental group will receive five minutes prefeeding oromotor stimulation in any consecutive two feedings for seven days and preterm neonates of control group will receive standard care as per institutional protocol. On day 1 and day 7 and on the day of introduction to oral feeding and on the day of full oral feeding feeding performance will be assessed by POFRAS score. Body weight will be also noted on day 1, and 7, on the day of introduction to oral feeding and on the day of full oral feeding, at the time of discharge from the neonatal record sheet as maintained in the unit. Duration of hospital stay of both the groups will be recorded. Following discharge at corrected age of 1 month, 3 months and at 6th month these babies will be followed up for their body weight and feeding performance.

 
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