Maternal Role in Oral Feed Establishment in Preterm Neonates

October 13, 2024 updated by: Rafia Gul, Fatima Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Shadman
      • Lahore, Shadman, Pakistan, 54610
        • Rafia Gul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (Group 1)

  • 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

  1. T1: Nurses performing all steps while mother observer status
  2. T2: Nurses perform all steps in front of the mother and a pacifier will be offered by the mother
  3. D1: Mother performs all steps and oral milk shall be offered by the nurse while the mother observes.
  4. D2: Mother performing all steps and offering oral milk while the nurse is supervising
  5. D3: Mother performing all steps independently
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
Sham Comparator: Control group (Group 2)
All steps will be the same as the intervention group and shall be performed by staff nurses
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Expected time of oral feed establishment
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.
For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14
•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 were noted on D1, D2,D3,D5,D7 and D14
•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
Adverse events were noted on D1, D2,D3,D5,D7 and D14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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
It was noted on D1, D2, D3, D5, D7 and D14
• 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
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
Time Frame: RT was measured on D1, D2, D3, D5, D7 and D14
RT is the time taken by neonate to finish oral feed
RT was measured on D1, D2, D3, D5, D7 and D14
• 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
OT was measured on D1, D2, D3, D5, D7 and D14
• 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
PRO % was measured on D1, D2, D3, D5, D7 and D14
• 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)
It was measured on D1, D2, D3, D5, D7 and D14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatima Memorial Hospital

Investigators

  • Principal Investigator: Rafia Gul, FCPS (Neo), Fatima Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

September 6, 2023

Study Registration Dates

First Submitted

July 30, 2022

First Submitted That Met QC Criteria

July 30, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMH-07-2021-IRB-929-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After approval from the publishing journal once the study has been completed

IPD Sharing Time Frame

1 year after the study's publication for 3 months

IPD Sharing Access Criteria

on request to corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Birth

Clinical Trials on perioral sensory motor stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe