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
|
|
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
|
|
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. |