Maternal Role in Oral Feed Establishment in Preterm Neonates

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: Recruiting
• Conditions: Preterm Birth; Swallowing Disorder; Tube Feeding; Maternal Care Patterns
• Intervention / Treatment: Other: perioral sensory motor stimulation

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 (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafia Gul, FCPS (Neo); Phone Number: +923064620027; Email: docrafiagul@gmail.com
• Study Contact Backup: Name: Saqib Aslam, FCPS( Paeds); Phone Number: 0923314797906; Email: saqib.aslam209@gmail.com

Study Locations

• Pakistan
  • Shadman
    • Lahore, Shadman, Pakistan, 54610
      • Recruiting
      • Rafia Gul
      • Contact: Rafia Gul, FCPS (Neo); Phone Number: +92923064620027; Email: docrafiagul@gmail.com
      • Contact: Saqib Aslam, FCPS (Peds); Phone Number: 0923314797906; Email: saqib.aslam209@gmail.com
      • Sub-Investigator: Saqib Aslam, FCPS (Peds)
      • Sub-Investigator: Zahid Anwar, FCPS (Neo)
      • Sub-Investigator: Fizza Yaqoob, MBBS
      • Sub-Investigator: Sidra Nayamat, RN
      • Sub-Investigator: Furqan Saleem, FCPS (Peds)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (Group 1); Maternal involvement shall be in three stages for the intervention group asObserver statusPerforming under supervisionIndependent; 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; 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 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

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Majoli M, De Angelis LC, Panella M, Calevo MG, Serveli S, Knoll BL, Ramenghi LA. Parent-Administered Oral Stimulation in Preterm Infants: A Randomized, Controlled, Open-Label Pilot Study. Am J Perinatol. 2021 Jun 28. doi: 10.1055/s-0041-1731452. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

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 (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Prematurity; sensory-motor stimulation; oral feed establishment; feeding intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Deglutition Disorders
• 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; Statistical Analysis Plan (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