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.
- Conditions
- Preterm [premature] newborn [other],
- Registration Number
- CTRI/2020/03/024061
- Lead Sponsor
- IPGMER and SSKM Hospital Kolkata
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 130
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Weight gain during hospital stay and in early infancy Duration of hospital stay
Trial Locations
- Locations (1)
IPGME&R SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
IPGME&R SSKM Hospital🇮🇳Kolkata, WEST BENGAL, IndiaSuvashri SasmalPrincipal investigator919831277932suvashri.sasmal@gmail.com