Maternal Role in Oral Feed Establishment in Preterm Neonates

Study Overview
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Brief Summary
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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
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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 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 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 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

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

Conditions
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Preterm Birth, Tube Feeding, Swallowing Disorder, Maternal Care Patterns

Intervention / Treatment
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* Other: perioral sensory motor stimulation


Participation Criteria
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Eligibility Criteria
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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, NEC(any stage) Major malformations Cleft lip and palate Anemia requiring blood transfusion

Ages Eligible for Study
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Minimum Age: 30 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Maternal involvement in perioral sensory-motor stimulation be in three stages Observer status Performing under supervision Independent Intervention period: 5 days as Training phase (T): T1 and T2 (for mothers by the nurse) Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate) Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs. Two groups Intervention group (GI): by mothers Control group (G II): by staff nurses
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (Group 1)<br>Maternal involvement shall be in three stages for the intervention group as Observer status Performing under supervision Independent Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes) Intervention group (Group I): by mothers T1: Nurses performing all steps while mother observer status T2: Nurses perform all steps in front of the mother and a pacifier will be offered by the mother D1: Mother performs all steps and oral milk shall be offered by the nurse while the mother observes. D2: Mother performing all steps and offering oral milk while the nurse is supervising D3: Mother performing all steps independently | Other: perioral sensory motor stimulation<br>* 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<br>|
| Sham Comparator: Control group (Group 2)<br>All steps will be the same as the intervention group and shall be performed by staff nurses | Other: perioral sensory motor stimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition time to full oral feeding | Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups | till 28 days of chronological age (expected time of oral feed establishment) | 
| improvement (change) in efficiency in oral feed establishment | 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 | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 
| •Adverse outcome monitoring | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with stimulation feed. | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Total volume taken during each feeding | how much feed has been taken orally out of total feed prescribed for each feeding | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 
| • Volume taken during the first 5 min of feeding (ml) | during each feed, out of total feed given orally, how much feed was taken by neonate during first 5 minutes | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 
| •Rate of transfer (RT) ml/min | How long it neonate takes to finish oral feed | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 
| • Overall transfer (OT percent) volume taken/total volume prescribed | trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 
| • Proficiency(PRO percent) volume taken during the first 5 min/total volume prescribed | how much amount of milk is taken during first 5 minutes while administering oral feeding | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 
| • SSB (Suck Swallow Breaths) coordination | coordinated , developed pattern of suck swallow and breath. monitor for any adverse events like cough, apnea | at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prematurity, sensory-motor stimulation, oral feed establishment, feeding intervention