Preterm Infant Oral Motor Intervention (PIOMI)

NCT06259604 | Not Yet Recruiting

• 1 other identifier: 009962
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

Conditions

Preterm Birth; Feeding Behavior

Keywords

Preterm newborn; Oral feeding; Kangaroo mother care; oral stimulation

Outcome Measures

Primary Outcomes (4)

• weight change

  The baby's weight chage will be recorded.

  Up to 14 days

• Early Feeding Skills Assessment Tool Scores

  Oral motor control will be evaluated.

  Before the intervention and on the 14th day of the intervention. The overall Early Feeding Skills Assessment Tool score is the sum of the 5 subscale scores and ranges from 19 to 57. Higher scores indicate more mature feeding skills.

• Transition time to full oral feeding

  The baby's transition to full oral feeding will be recorded.

  Up to 14 days

• Discharge period

  The time from hospital admission to discharge will be calculated.

  through the baby's hospital admission to discharge

Study Arms (3)

PIOMI

EXPERIMENTAL

Babies in this group will be administered PIOMI once a day, 30-45 minutes before feeding, for 14 days. When the intervention ends, the baby's feeding will be carried out by the researcher neonatal nurse in a semi-elevated side position, taking into account cue-based feeding symptoms, and the transition to full oral feeding will be evaluated by two researchers. These babies will be evaluated with the Early Feeding Skills Assessment Tool for early feeding skills before any intervention is applied (day 0) and on the 14th day of the PIOMI intervention. In addition, the weight of the babies will be monitored every morning for 14 days, on an empty stomach and naked, and will be recorded in the Nutrition Tracking Chart. The time it takes for babies to transition to full oral feeding will be evaluated according to cue-based feeding and recorded in the Feeding Follow-Up Chart.

Other: PIOMI

PIOMI+kangaroo care

EXPERIMENTAL

Babies in this group will start using PIOMI once a day, 30-45 minutes before feeding, and kangaroo care for at least 30 minutes during the last 2 minutes of non-nutritive sucking phase of PIOMI, for 14 days. When the intervention ends, the baby's feeding will be carried out by the researcher neonatal nurse in a semi-elevated side position, taking into account cue-based feeding symptoms, and the transition to full oral feeding will be evaluated by two researchers. These babies will be evaluated with the Early Feeding Skills Assessment Tool before any intervention is applied (day 0) and on the 14th day of PIOMI+kangaroo care in terms of early feeding skills. In addition, the weight of the babies will be monitored every morning for 14 days, on an empty stomach and naked, and will be recorded in the Nutrition Tracking Chart. The time it takes for babies to transition to full oral feeding will be evaluated according to cue-based feeding and recorded in the Feeding Follow-Up Chart.

Other: PIOMI+kangaroo care

Control

NO INTERVENTION

Babies in this group will receive standard care in the clinic. They will be evaluated with the Early Nutrition Skills Assessment Tool in terms of early feeding skills on the day they are included in the study (day 0) and on the 14th day. In addition, the weight of the babies will be monitored every morning for 14 days, on an empty stomach and naked, and will be recorded in the Nutrition Tracking Chart. The time it takes for babies to transition to full oral feeding will be evaluated according to cue-based feeding and recorded in the Feeding Follow-Up Chart. All measurements will be carried out and evaluated separately by two independent researchers. During discharge, discharge time, discharge weight and postmenstrual week at discharge will be recorded in the Baby Information Form.

Interventions

PIOMI OTHER

Babies in this group will be administered PIOMI once a day, 30-45 minutes before feeding, for 14 days.

PIOMI

PIOMI+kangaroo care OTHER

Babies in this group will start using PIOMI once a day, 30-45 minutes before feeding, and kangaroo care for at least 30 minutes during the last 2 minutes of non-nutritive sucking phase of PIOMI, for 14 days.

PIOMI+kangaroo care

Eligibility Criteria

• Age: 29 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age at birth is 28-32 weeks, depending on the mother's last menstrual period,
• can be administered PIOMI per week and can tolerate the transition to oral feeding,
• Able to tolerate the transition to oral feeding according to the cue-based feeding model,
• Maintains physiological stabilization (heart rate, oxygen saturation, respiratory rate) during the procedure when oxygen support is provided with room air or nasal cannula or hood.
• Apgar score of 4 or higher at the 5th minute after birth
• Not receiving mechanical ventilator support or 48 hours after weaning from mechanical ventilator support
• Babies with written and verbal permission from their parents will be included in the research.

You may not qualify if:

• Those with congenital anomalies (cleft lip, cleft palate, gastroschisis, omphalocele, short bowel syndrome and other anomalies) According to the criteria of Jobe and Bancalari (2001), patients with severe bronchopulmonary dysplasia and patent ductus arteriosus (PDA) requiring surgical treatment Babies with gastrointestinal, neurological and genetic diseases (necrotizing enterocolitis, level 3 and 4 intracranial hemorrhage, periventricular 25 leukomalacia, hydrocephalus, down syndrome) will not be included in the study.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Isparta City Hospital

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Feeding Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Şerife Tutar, Dr.

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Şerife Tutar, Dr.

CONTACT

+905053126429; serifeguven@sdu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: One-sided blinding method will be applied in the research. Only one of the researchers has a PIOMI practitioner certificate and interventions will be carried out only by this researcher. The PIOMI practitioner researcher will perform all interventions of PIOMI and combined methods himself and will not tell other researchers which group the babies are in. All measurements of the babies, except PIOMI, will be carried out by a single researcher in the research group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)