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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.

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. - ROMS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024061
Enrollment
130
Registered
2020-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: 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 m

Sponsors

IPGMER and SSKM Hospital Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn, preterms born between 26 0/7- 32 0/7 weeks gestational age, hemodynamically stable and receiving motherâ??s milk as gavage feeds atleast 100ml/day will be included. Mother as the primary caregiver at SNCU

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 monthsTimepoint: 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

MeasureTime frame
Weight gain during hospital stay and in early infancy Duration of hospital stayTimepoint: 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

Countries

India

Contacts

Public ContactDr Asha P Shetty

IPGME&R and SSKM Hospital

bijansaha18@gmail.com9051389120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026