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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484726
• Other study ID #: FMH-07-2021-IRB-929-M
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Fatima Memorial Hospital
• Contact: Rafia Gul, FCPS (Neo)
• Phone: +923064620027
• Email: docrafiagul[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Pakistan	Rafia Gul	Lahore	Shadman

Sponsors (1)

Lead Sponsor	Collaborator
Fatima Memorial Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (16)

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr. 1997 Apr;130(4):561-9. — View Citation

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. — View Citation

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. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	•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	• 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
Secondary	• 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
Secondary	•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
Secondary	• 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
Secondary	• 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
Secondary	• 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