Maternal Role in Oral Feed Establishment in Preterm Neonates

NCT05484726 | Completed Results DMC

• 1 other identifier: FMH-07-2021-IRB-929-M
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will

1. 1.Start taking oral feed at the same time as compared to control group
2. 2.Take the same amount of milk at the commencement of oral feeding
3. 3.Take milk with equal efficiency
4. 4.Not face more adverse effects

Conditions

Preterm Birth; Tube Feeding; Swallowing Disorder; Maternal Care Patterns

Keywords

Prematurity; sensory-motor stimulation; oral feed establishment; feeding intervention

Outcome Measures

Primary Outcomes (4)

• 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.

  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 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

  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

  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 Outcomes (6)

• • Total Volume Taken During Each Feeding

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

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

  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

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

• • Overall Transfer (OT Percent) Volume Taken/Total Volume 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

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

Study Arms (2)

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

Other: perioral sensory motor stimulation

Control group (Group 2)

SHAM COMPARATOR

All steps will be the same as the intervention group and shall be performed by staff nurses

Other: perioral sensory motor stimulation

Interventions

perioral sensory motor stimulation OTHER

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

Control group (Group 2); Intervention group (Group 1)

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatima Memorial Hospital: lead

Study Sites (1)

Rafia Gul

Lahore, Shadman, 54610, Pakistan

Location

Related Publications (16)

• 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.

  PMID: 32903261 BACKGROUND

• 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.

  PMID: 29190845 BACKGROUND

• 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.

  PMID: 22254018 BACKGROUND

• 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.

  PMID: 31366911 BACKGROUND

• 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.

  PMID: 27644167 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30817764 BACKGROUND

• 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.

  PMID: 22675368 BACKGROUND

• 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.

  PMID: 12205253 BACKGROUND

• 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.

  PMID: 9108854 BACKGROUND

• 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.

  PMID: 30898170 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30851536 BACKGROUND

• 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.

  PMID: 21707601 BACKGROUND

• 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.

  PMID: 21212698 BACKGROUND

• 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. 2023 Jun;40(8):845-850. doi: 10.1055/s-0041-1731452. Epub 2021 Jun 28.

  PMID: 34182577 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Deglutition Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Assistant Professor Dr Rafia Gul
• Organization: Fatima Memorial Hospital Shadman Lahore

docrafiagul@gmail.com

00923064620027

Study Officials

• Rafia Gul, FCPS (Neo)

  Fatima Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 6, 2023
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after the study's publication for 3 months
• Access Criteria: on request to corresponding author

Locations

PA (1)