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Completed

NCT Number: NCT05484726

Maternal Role in Oral Feed Establishment in Preterm Neonates

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

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Key information

Conditions

Preterm Birth Deglutition Disorders Digestive System Diseases Esophageal Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Maternal Care Patterns Obstetric Labor Complications Obstetric Labor, Premature Otorhinolaryngologic Diseases Pharyngeal Diseases Pregnancy Complications Premature Birth Swallowing Disorder Tube Feeding Urogenital Diseases

Age range

30 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rafia Gul

Lahore, Shadman, 54610, Pakistan

About this study

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
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perioral sensory motor stimulation

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. •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

    • stimulation
    • 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

  4. •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

    • stimulation
    • 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

  1. • Total Volume Taken During Each Feeding

    Time frame: It was noted on D1, D2, D3, D5, D7 and D14

    It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding

  2. • Volume Taken During the First 5 Min of Feeding (ml) VT5

    Time frame: Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14

    during each feed taken orally by neonate VT5 is the amount of feed was taken by neonate during first 5 minutes

  3. •Rate of Transfer (RT) ml/Min

    Time frame: RT was measured on D1, D2, D3, D5, D7 and D14

    RT is the time taken by neonate to finish oral feed

  4. • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed

    Time frame: OT was measured on D1, D2, D3, D5, D7 and D14

    trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed

  5. • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed

    Time frame: PRO % was measured on D1, D2, D3, D5, D7 and D14

    how much amount of milk is taken during first 5 minutes while administering oral feeding

  6. • Neonates Feeding With SSB Coordination

    Time frame: It was measured on D1, D2, D3, D5, D7 and D14

    number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB)

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2022
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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