Maternal Role in Oral Feed Establishment in Preterm Neonates

• Sponsor: Fatima Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05484726
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth; Tube Feeding; Swallowing Disorder; Maternal Care Patterns	Other: perioral sensory motor stimulation	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Maternal involvement in perioral sensory-motor stimulation be in three stages Observer status Performing under supervision Independent Intervention period: 5 days as Training phase (T): T1 and T2 (for mothers by the nurse) Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate) Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs. Two groups Intervention group (GI): by mothers Control group (G II): by staff nursesMaternal involvement in perioral sensory-motor stimulation be in three stages Observer status Performing under supervision Independent Intervention period: 5 days as Training phase (T): T1 and T2 (for mothers by the nurse) Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate) Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs. Two groups Intervention group (GI): by mothers Control group (G II): by staff nurses
• Masking: Single (Care Provider)
• Masking Description: The mothers, medical staff involved in general care, nursing staff involved in the intervention, and doctors conducting the assessment of oral feeding skills (OFS) were all blinded to allocation. The nursing staff was informed at the time of intervention that participating infants would receive either sensory motor stimulation or sham oral stimulation depending on group allocation.
• Primary Purpose: Supportive Care
• Official Title: Maternal Role in Sensory-motor Stimulation for Oral Feed Establishment in Preterm Neonates: MSMS Trial
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

1. Transition time to full oral feeding [till 28 days of chronological age (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

2. improvement (change) in efficiency in oral feed establishment [at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age]

   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

3. •Adverse outcome monitoring [at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age]

   monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with stimulation feed.

Secondary Outcome Measures

1. • Total volume taken during 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]

   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) [at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age]

   during each feed, out of total feed given orally, how much feed was taken by neonate during first 5 minutes

3. •Rate of transfer (RT) 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]

   How long it neonate takes to finish oral feed

4. • Overall transfer (OT percent) volume taken/total volume prescribed [at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age]

   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 [at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age]

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

6. • SSB (Suck Swallow Breaths) coordination [at time of stimulation and feeding, twice a day at 11.00 am and 05.00 pm till 28 days of chronological age]

   coordinated , developed pattern of suck swallow and breath. monitor for any adverse events like cough, apnea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Weeks to 34 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rafia Gul	Lahore	Shadman	Pakistan	54610

Sponsors and Collaborators

• Fatima Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr. 1997 Apr;130(4):561-9.
• 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. [Epub ahead of print]
• 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.
• 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.
• Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22.
• 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.
• 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.

• Responsible Party: Rafia Gul, Assistant Professor, Fatima Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05484726
• Other Study ID Numbers: FMH-07-2021-IRB-929-M
• First Posted: Aug 2, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rafia Gul, Assistant Professor, Fatima Memorial Hospital: Prematurity; sensory-motor stimulation; oral feed establishment; feeding intervention
• Additional relevant MeSH terms: Deglutition Disorders; Premature Birth

Study Results

No Results Posted as of Aug 5, 2022