NCT05484726

Maternal Role in Oral Feed Establishment in Preterm Neonates

Maternal Role in Sensory-motor Stimulation for Oral Feed Establishment in Preterm Neonates: MSMS Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Fatima Memorial Hospital · Academic / Other
• Sex: All
• Age: 30 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1. Start taking oral feed at the same time as compared to control group 2. Take the same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. 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 1. Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding 2. Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses 3. 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 1\. 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 1. Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation 2. 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) 3. Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered) 4. 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 * Total volume prescribed (ml) * Total volume has taken during feeding (ml) * Volume has taken during the first 5 min of feeding (ml) * Duration of oral feeding (min) * Overall transfer (OT %) volume taken/total volume prescribed * Proficiency(PRO%) volume taken during the first 5 min/total volume prescribed * Rate of transfer (RT) ml/min * SSB (Suck Swallow Breaths) coordination * Adverse events (cough, fatigue) * According to this oral feeding ability 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

Conditions

• Preterm Birth
• Tube Feeding
• Swallowing Disorder
• Maternal Care Patterns

Interventions

Type	Name	Description
OTHER	perioral sensory motor stimulation	Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-05-01
• Completion: 2023-09-06
• First posted: 2022-08-02
• Last updated: 2024-12-02
• Results posted: 2024-12-02

Locations

1 site across 1 country: Pakistan