Maternal Role in Oral Feed Establishment in Preterm Neonates

Preterm Birth Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Deglutition Disorders
• Maternal Care Patterns
• Premature Birth
• Preterm Birth
• Swallowing Disorder
• Tube Feeding

• NCT number: NCT05484726
• Study type: Interventional
• Source: Fatima Memorial Hospital
• Contact: Rafia Gul, FCPS (Neo)
• Phone: +923064620027
• Email: docrafiagul@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Completion date: December 2022