Oral Motor Intervention to Preterms by Their Mothers

NCT06194513 | Unknown

• 1 other identifier: 09.2023.1690
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified. Oral Motor Intervention (PIOMI) will be taught to the mothers of these babies and asked to practice. As a result of this application, the change in oral feeding skills in babies and its effect on mother-infant bonding will be evaluated.

Conditions

Premature

Keywords

The Motor to Infant Bonding Scale; Preterm Infant Oral Feeding Readiness Assessment; The Breastfeeding Assessment Tool

Outcome Measures

Primary Outcomes (2)

• The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position)

  LATCH is a tool created by analogy with the Apgar score system in terms of scoring method, and its evaluation is quick and easy. The Turkish validity of the Assessment Tool was conducted by Demirhan in 1997, Koyun in 2001, and Yenal and Okumuş in 2003, and it was recommended to be used as a reliable tool. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success. Cronbach Alpha value of the LATCH Breastfeeding Assessment Tool; Yenal and Okumuş found it as 0.95, Demirhan as 0.94, and Koyun as 0.96. The scale considers mother and baby together. It can be evaluated by a healthcare professional or the mother. In the evaluation; It includes the criteria for breast retention, the baby's swallowing movement, the type of nipple, the mother's comfort with the breast and nipple, and the position of holding the baby.

  0, 7. day, 14. day

• Preterm Infant Oral Feeding Readiness Assessment (PIOFRA/ POFRAS)

  This scale consists of 5 categories (corrected gestational age, behavioral organization, mouth posture, oral reflexes, non-nutritive sucking) and 18 items and evaluates readiness for oral feeding in preterm infants. The scale is scored between 0-2 and the maximum score is 36. The cut-off point for switching a preterm baby to oral feeding was determined as 30 . Turkish Validity-Reliability: In the Turkish adaptation of this scale made by Çamur and Çetinkaya in 2020, the cut-off point was found to be 29.

  0, 7. day, 14. day

Secondary Outcomes (1)

• The Mother to Infant Bonding Scale (MIBS)

  0, 7. day, 14. day

Study Arms (3)

Intervention 1: Twice a day for 1 week PIOMI

EXPERIMENTAL

Mothers of preterm babies in this group who have oral feeding difficulties will be taught Oral Motor Intervention (PIOMI) and asked to apply it. During the applications, visual monitoring of the application will be provided via video call, and objective monitoring of the application will be provided with the PIOMI Reliability Assessment Tool.

Other: Intervention 1: Twice a day for 1 week PIOMI

Intervention 2: Once a day for 2 weeks PIOMI

EXPERIMENTAL

Mothers of preterm babies in this group who have oral feeding difficulties will be taught Oral Motor Intervention (PIOMI) and asked to apply it. During the applications, visual monitoring of the application will be provided via video call, and objective monitoring of the application will be provided with the PIOMI Reliability Assessment Tool.

Other: Intervention 2: Once a day for 2 weeks PIOMI

Control

NO INTERVENTION

In the control group, no extra intervention will be given to preterm babies who have difficulty in oral feeding, and oral activation will be provided only with a pacifier.

Interventions

Intervention 1: Twice a day for 1 week PIOMI OTHER

Preterm babies will receive two sessions of treatment every day for a week, for a total of 14 sessions. Each session will be five minutes. The application is done at a time when the baby is peaceful and not very hungry. When the application is performed, the baby is positioned on his back and in a way that feels comfortable.

Intervention 1: Twice a day for 1 week PIOMI

Intervention 2: Once a day for 2 weeks PIOMI OTHER

Preterm babies will receive a total of 14 sessions of treatment, one every day for two weeks. Each session will be five minutes. The application is done at a time when the baby is peaceful and not very hungry. When the application is performed, the baby is positioned on his back and in a way that feels comfortable.

Intervention 2: Once a day for 2 weeks PIOMI

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participation in the study is accepted by the family
• PIOMI can be applied and whose clinical condition is stable,
• Born earlier than 37 weeks,
• Those who have not been diagnosed with any disorder in swallowing functions,
• Without congenital anomalies and systemic diseases,
• Vital signs are stable,
• Babies without congenital anomalies or serious complications

You may not qualify if:

• Participation in the study is not accepted by their family,
• Those with congenital anomalies and systemic diseases.
• Those who have been diagnosed with swallowing disorder,
• Those with congenital disorders or birth trauma,
• Diagnosed with severe asphyxia,
• Those with intraventricular bleeding,
• Those with Neonatal Abstinence Syndrome,
• Those with Fetal Alcohol Syndrome,
• Babies connected to a ventilator

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Related Publications (5)

• Hegazy SM. Late Preterm Infants. A Guide for Nurses, Midwives, Clinicians, and Allied Health Professionals. Saudi Med J. 2019 Dec;40(12):1303. doi: 10.15537/smj.2019.12.24665.

  PMID: 31828286 BACKGROUND

• Cerro N, Zeunert S, Simmer KN, Daniels LA. Eating behaviour of children 1.5-3.5 years born preterm: parents' perceptions. J Paediatr Child Health. 2002 Feb;38(1):72-8. doi: 10.1046/j.1440-1754.2002.00728.x.

  PMID: 11869405 BACKGROUND

• Gewolb IH, Vice FL. Maturational changes in the rhythms, patterning, and coordination of respiration and swallow during feeding in preterm and term infants. Dev Med Child Neurol. 2006 Jul;48(7):589-94. doi: 10.1017/S001216220600123X.

  PMID: 16780629 BACKGROUND

• Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.

  PMID: 8176525 BACKGROUND

• Fujinaga CI, de Moraes SA, Zamberlan-Amorim NE, Castral TC, de Almeida e Silva A, Scochi CG. Clinical validation of the Preterm Oral Feeding Readiness Assessment Scale. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:140-5. doi: 10.1590/s0104-11692013000700018. English, Portuguese.

  PMID: 23459901 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aylin Demirci, PT

  Marmara University

  PRINCIPAL INVESTIGATOR

• Evrim Karadag Saygi, Prof

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Aylin Demirci, PT

CONTACT

+905423228612; fzt.aylindemirci@gmail.com

Evrim Karadag Saygi, Prof

CONTACT

evrimkaradag4@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The infants included in the study will be divided to 3 groups and will be treated at the same time as a control group and 2 treatment groups.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 8, 2024
• Study Start: January 10, 2024
• Primary Completion: January 30, 2024
• Study Completion: February 29, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)