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Preterm BirthNCT05484726

Maternal Role in Oral Feed Establishment in Preterm Neonates

A study testing perioral sensory motor stimulation in people with Preterm Birth and Tube Feeding, run by Fatima Memorial Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 34 weeksHealthy volunteers can take part
Conditions the study is for
Preterm Birth, Tube Feeding, Swallowing Disorder
What is being tested?
perioral sensory motor stimulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
1 sitePakistan
Study dates
1 Mar 2022to 6 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 34 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Rafia Gul

    Lahore, Shadman, 54610

Other trials in Pakistan

About this study

Official title: 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
Read the 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
  4. 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
Being tested
perioral sensory motor stimulation
Keywords
Prematurity, sensory-motor stimulation, oral feed establishment, feeding intervention
Medical subject headings
Premature Birth, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perioral sensory motor stimulationOther

    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

Study groups in NCT05484726
Study groupRoleWhat they receive
Intervention group (Group 1)Experimental* 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
Receives: Other: perioral sensory motor stimulation
Control group (Group 2)Sham comparatorAll steps will be the same as the intervention group and shall be performed by staff nurses
Receives: Other: perioral sensory motor stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. 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.

    Measured: Expected time of oral feed establishment

  2. 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 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.

    Measured: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14

  3. •Adverse Outcome Monitoring

    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

    Measured: Adverse events were noted on D1, D2,D3,D5,D7 and D14

  4. •Adverse Events Monitoring

    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

    Measured: Adverse events were noted on D1, D2,D3,D5,D7 and D14

Secondary outcomes (6)

  1. • Total Volume Taken During Each Feeding

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

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

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

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

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

  3. •Rate of Transfer (RT) ml/Min

    RT is the time taken by neonate to finish oral feed

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

  4. • 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

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

  5. • 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

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

  6. • Neonates Feeding With SSB Coordination

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start1 Mar 2022
  3. Primary completion1 May 2023
  4. Study completion6 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Model description
1. Maternal involvement in perioral sensory-motor stimulation be in three stages 1. Observer status 2. Performing under supervision 3. Independent 2. Intervention period: 5 days as 1. Training phase (T): T1 and T2 (for mothers by the nurse) 2. Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate) 3. Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs. 4. Two groups 1. Intervention group (GI): by mothers 2. Control group (G II): by staff nurses
Masking
Single blind
Who is masked
Care provider
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484726
Sponsor's protocol ID
FMH-07-2021-IRB-929-M
Status last verified
Oct 2024
First submitted
30 Jul 2022
Last updated
2 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After approval from the publishing journal once the study has been completed

Publications

  • da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020.

    PubMed 32903261

  • Murthy SV, Funderburk A, Abraham S, Epstein M, DiPalma J, Aghai ZH. Nasogastric Feeding Tubes May Not Contribute to Gastroesophageal Reflux in Preterm Infants. Am J Perinatol. 2018 Jun;35(7):643-647. doi: 10.1055/s-0037-1608875. Epub 2017 Nov 30.

    PubMed 29190845

  • Rogers SP, Hicks PD, Hamzo M, Veit LE, Abrams SA. Continuous feedings of fortified human milk lead to nutrient losses of fat, calcium and phosphorous. Nutrients. 2010 Mar;2(3):230-40. doi: 10.3390/nu2030240. Epub 2010 Feb 26.

    PubMed 22254018

  • Viswanathan S, Jadcherla S. Transitioning from gavage to full oral feeds in premature infants: When should we discontinue the nasogastric tube? J Perinatol. 2019 Sep;39(9):1257-1262. doi: 10.1038/s41372-019-0446-2. Epub 2019 Jul 31.

    PubMed 31366911

  • Greene Z, O'Donnell CP, Walshe M. Oral stimulation for promoting oral feeding in preterm infants. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009720. doi: 10.1002/14651858.CD009720.pub2.

    PubMed 27644167

  • 6. Maltese A, Gallai B, Marotta R, Lavano F, Lavano S, Tripi G. The synactive theory of development: the keyword for neurodevelopmental disorders. Acta Medica Mediterranea, 2017, 33: 1257-63

  • Song D, Jegatheesan P, Nafday S, Ahmad KA, Nedrelow J, Wearden M, Nemerofsky S, Pooley S, Thompson D, Vail D, Cornejo T, Cohen Z, Govindaswami B. Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial. PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019.

    PubMed 30817764

  • Bertoncelli N, Cuomo G, Cattani S, Mazzi C, Pugliese M, Coccolini E, Zagni P, Mordini B, Ferrari F. Oral feeding competences of healthy preterm infants: a review. Int J Pediatr. 2012;2012:896257. doi: 10.1155/2012/896257. Epub 2012 May 17.

    PubMed 22675368

  • Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22. doi: 10.1542/peds.110.3.517.

    PubMed 12205253

  • Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr. 1997 Apr;130(4):561-9. doi: 10.1016/s0022-3476(97)70240-3.

    PubMed 9108854

  • Sarin E, Maria A. Acceptability of a family-centered newborn care model among providers and receivers of care in a Public Health Setting: a qualitative study from India. BMC Health Serv Res. 2019 Mar 21;19(1):184. doi: 10.1186/s12913-019-4017-1.

    PubMed 30898170

  • 13. Fonseca SA, Silveira AO, Franzoi MAH, Motta E. Family centered-care at the neonatal intensive care unit (NICU): nurses' experiences. Enfermería: Cuidados Humanizados. 2020; 9(2): 170-190

  • Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.

    PubMed 30851536

  • Fucile S, Gisel EG, McFarland DH, Lau C. Oral and non-oral sensorimotor interventions enhance oral feeding performance in preterm infants. Dev Med Child Neurol. 2011 Sep;53(9):829-835. doi: 10.1111/j.1469-8749.2011.04023.x. Epub 2011 Jun 27.

    PubMed 21707601

  • Lau C, Smith EO. A novel approach to assess oral feeding skills of preterm infants. Neonatology. 2011;100(1):64-70. doi: 10.1159/000321987. Epub 2011 Jan 5.

    PubMed 21212698

Questions about this trial

What is this clinical trial studying?

A study testing perioral sensory motor stimulation in people with Preterm Birth and Tube Feeding, run by Fatima Memorial Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transition Time to Full Oral Feeding (time frame: Expected time of oral feed establishment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484726, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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