Maternal Role in Sensory-motor Stimulation for Oral Feed Establishment in Preterm Neonates: MSMS Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fatima Memorial Hospital
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Transition Time to Full Oral Feeding
Study Overview
Brief Summary
Hypothesis
Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will
- Start taking oral feed at the same time as compared to control group
- Take the same amount of milk at the commencement of oral feeding
- Take milk with equal efficiency
- Not face more adverse effects
Detailed Description
Aim To determine the maternal role in sensory-motor stimulation for oral feed establishment in preterm neonates Objective
-
Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding
-
Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses
-
Study maternal role in the establishment of oral feed Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will
-
Start taking oral feed at the same time frame as compared to the control group 2. Take the very same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. There is no extra burden of adverse effects
Data Collection All on going and related trials for this intervention shall be registered in the ClinicalTrials.gov. Study shall be conducted after ethical approval from IRB. All participants shall be enrolled after written informed consent from mothers after approval from attending neonatologist (annexure 2). All relevant maternal and neonatal data shall be collected on a specially designed proforma (annexure 3) with following details
- Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation
- Part 2: Neonatal demographic data (gender, gestation age, birth weight, growth centiles, diagnosis, APGAR score, noninvasive (NIV) and invasive ventilation with duration, caffeine, days taken for establishment of gavage feeding, age, and weight at commencement of intervention, any other complication during study)
- Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered)
- Part 4: Oral feeding skill (OFS) assessment adapted from the model presented by Lau and Smith (p). All parameters shall be recorded twice a day for D1, D2, and D3 separately. It includes
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Masking Description
The mothers, medical staff involved in general care, nursing staff involved in the intervention, and doctors conducting the assessment of oral feeding skills (OFS) were all blinded to allocation. The nursing staff was informed at the time of intervention that participating infants would receive either sensory motor stimulation or sham oral stimulation depending on group allocation.
Eligibility Criteria
- Ages
- 30 Weeks to 34 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All preterm of gestation age 28 to 34weeks
- •Haemodynamically stable
- •Established full Gavage feed
- •No respiratory distress
- •No need for respiratory support except LFNC
- •Do not receive any kind of analgesics
Exclusion Criteria
- •Syndromic babies /genetic disorders
- •Haemodynamically unstable babies including IVH (grade III & IV), hemodynamically significant PDA on treatment, NEC(stage III)
- •Major malformations
- •Cleft lip and palate
- •Anemia requiring blood transfusion
Outcomes
Primary Outcomes
Transition Time to Full Oral Feeding
Time Frame: Expected time of oral feed establishment
Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day.
Improvement (Change) in Efficiency in Oral Feed Establishment
Time Frame: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14
According to this efficiency in oral feed establishment in terms of amount and time is determined for the intervention group vs the control group. It can be classified into four levels depending upon the level of maturity in ascending order as follows: * Level 1: PRO \< 30% and RT \< 1.5 ml/min * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min For all neonates, efficacy was measured at 11.00 am and 5.00 pm following sensory motor stimulation for both groups till achievement of full oral feed.
•Adverse Outcome Monitoring
Time Frame: Adverse events were noted on D1, D2,D3,D5,D7 and D14
monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
•Adverse Events Monitoring
Time Frame: Adverse events were noted on D1, D2,D3,D5,D7 and D14
monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
Secondary Outcomes
- • Total Volume Taken During Each Feeding(It was noted on D1, D2, D3, D5, D7 and D14)
- • Volume Taken During the First 5 Min of Feeding (ml) VT5(Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14)
- •Rate of Transfer (RT) ml/Min(RT was measured on D1, D2, D3, D5, D7 and D14)
- • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed(OT was measured on D1, D2, D3, D5, D7 and D14)
- • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed(PRO % was measured on D1, D2, D3, D5, D7 and D14)
- • Neonates Feeding With SSB Coordination(It was measured on D1, D2, D3, D5, D7 and D14)
Investigators
Rafia Gul
Assistant Professor
Fatima Memorial Hospital