The Effect of The Premature Infant Oral Motorınterventıon on Suckıng Capacıty in Preterm Infants

NCT04835155 | Completed

• 1 other identifier: Hasan Kalyoncu University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT Objective: To test the effect of the Premature Infant Oral Motor Intervention (PIOMI) at 29-30 weeks post-menstrual age on the development of oral-motor function and sucking capacity. Study Design: This study was a single-blind randomized controlled experimental design. The sample consisted of 60 preterm babies from two Neonatal Intensive Care Units in Gaziantep, Turkey between May 2019 and March 2020, with 30 each in the control and experimental groups. The PIOMI was applied to the experimental group for five minutes a day for 14 consecutive days. Sucking capacity, growth, feeding outcomes, and length of hospital stay (LOS) were measured. The Yakut Manometer Measuring Suction Power (PCT/TR2019/050678) was developed specifically for this study and tested for the first time.

Conditions

Feeding Behavior; Premature Birth; Sucking Behavior

Keywords

Preterm Infant; Sucking Capacity; Premature Infant Oral Motor Intervention; Feeding; Oral Stimulation

Outcome Measures

Primary Outcomes (4)

• Baby's sucking power

  The suction power of the baby was measured in mmHg with the Manometer measuring the Sucking Power.

  The sucking power of the baby included in the study was measured up to 32 weeks.

• Baby's sucking before releasing the bottle

  The baby's sucking time without leaving the bottle was calculated in seconds.

  The sucking time without leaving the bottle of the baby included in the study was measured up to 32 weeks.

• Baby's total sucking time

  The baby's total sucking time was calculated in seconds.

  The total sucking time of the baby included in the study was measured up to 32 weeks.

• Baby's sucking amount

  The baby's sucking amount was calculated in milliliters.

  The sucking amount of the baby included in the study was measured up to 32 weeks.

Secondary Outcomes (5)

• Baby's body weight

  The baby's body weight was measured for up to 40 weeks.

• Baby's height

  Baby's height was measured for up to 40 weeks.

• Baby's head circumference

  Baby's head circumference was measured for up to 40 weeks.

• First day of oral feeding time

  The day when the baby was able to have the first oral feeding was measured up to 40 weeks.

• Discharge time

  Up to 40 weeks were measured on the day of discharge.

Study Arms (2)

experimental group

EXPERIMENTAL

The researcher applied Premature Infant Oral Motor Intervention to the experimental group for 5 minutes per day for 14 consecutive days, 15-20 minutes before a sheduled feeding at either the 09:00 or 12:00 feeding. On the first day, the baseline sucking capacity of babies in experimental group was measured before any intervention. On the following 8th, 11th and 14th days, the measures of sucking capacity were repeated and followed by oral feeding trials. Growth measures were collected on the 1st and 14th days and the day of disharge.

Procedure: Premature Infant Oral Motor Intervention (PIOMI)

control grup

NO INTERVENTION

The researcher did not apply any intervention. On the first day, the baseline sucking capacity of babies in control group was measured before any intervention. On the following 8th, 11th and 14th days, the measures of sucking capacity were repeated and followed by oral feeding trials.

Interventions

Premature Infant Oral Motor Intervention (PIOMI) PROCEDURE

The Premature Infant Oral Motor Intervention (PIOMI), developed by Dr. Brenda Lessen Knoll, was chosen for this study because it is the only oral motor program designed specifically for preterm babies as young as 29 weeks post menstrual age (PMA) and is the only program with a standardized training method and published intervention fidelity. The 5 minute therapy offers assisted movement to activate muscle contraction and movement against resistance to build strength in the perioral structures. The PIOMI has 8 steps where a provider uses a pinky finger to provide gentle stroking and pressure on the cheeks, lips, tongue, gums and palate to strengthen the oral sensory-motor functions and improve feeding efficiency. PIOMI ends with 2 minutes of NNS. NNS and oral stimulation have been found to mature the oral motor sensory system, and improve not only bottle feeding, but also breastfeeding.

experimental group

Eligibility Criteria

• Age: 29 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• babies born at 26-30 weeks PMA,
• stable clinical condition,
• vital signs stable for at least 24 hours,
• able to have PIOMI by the 29th or 30th week PMA,
• required respiratory support limited to an oxyhood, Continuous Positive Airway Pressure (CPAP) and/or nasal cannula up to 2L flow,
• APGAR scores at 1- and 5-minutes of 4 and above,
• any race or ethnicity,
• intraventricular hemmorhage limited to level 1 or 2; and
• had no birth defects including facial anomolies that would impact feeding.

You may not qualify if:

• Whose gestational age at birth was less than 26 weeks,
• had congenital disorder or birth trauma,
• had NEC,
• had RDS,
• were diagnosed with severe asphyxia,
• had intraventricular bleeding,
• had Newborn Withdrawal Syndrome,
• had Fetal Alcohol Syndrome,
• were receiving ventilator support,
• were receiving Extracorporeal Membrane Oxygenation,
• developed any complications during the follow-up period in the intervention group, whose balance status deteriorated,
• whose written and verbal permissions were obtained from their parents.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University, Faculty of Health Sciences, Department of Nursing

Gaziantep, Şahinbey, 27412, Turkey (Türkiye)

Location

Related Publications (8)

• Tian X, Yi LJ, Zhang L, Zhou JG, Ma L, Ou YX, Shuai T, Zeng Z, Song GM. Oral Motor Intervention Improved the Oral Feeding in Preterm Infants: Evidence Based on a Meta-Analysis With Trial Sequential Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1310. doi: 10.1097/MD.0000000000001310.

  PMID: 26252313 RESULT

• Lessen Knoll BS, Daramas T, Drake V. Randomized Controlled Trial of a Prefeeding Oral Motor Therapy and Its Effect on Feeding Improvement in a Thai NICU. J Obstet Gynecol Neonatal Nurs. 2019 Mar;48(2):176-188. doi: 10.1016/j.jogn.2019.01.003. Epub 2019 Feb 2.

  PMID: 30721652 RESULT

• Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.

  PMID: 12183719 RESULT

• Lessen BS. Effect of the premature infant oral motor intervention on feeding progression and length of stay in preterm infants. Adv Neonatal Care. 2011 Apr;11(2):129-39. doi: 10.1097/ANC.0b013e3182115a2a.

  PMID: 21730902 RESULT

• Lessen BS, Morello CA, Williams LJ. Establishing Intervention Fidelity of an Oral Motor Intervention for Preterm Infants. Neonatal Netw. 2015;34(2):72-82. doi: 10.1891/0730-0832.34.2.72.

  PMID: 26803089 RESULT

• Kamitsuka MD, Nervik PA, Nielsen SL, Clark RH. Incidence of Nasogastric and Gastrostomy Tube at Discharge Is Reduced after Implementing an Oral Feeding Protocol in Premature (< 30 weeks) Infants. Am J Perinatol. 2017 May;34(6):606-613. doi: 10.1055/s-0037-1601443. Epub 2017 Apr 4.

  PMID: 28376549 RESULT

• Li XL, Liu Y, Liu M, Yang CY, Yang QZ. Early Premature Infant Oral Motor Intervention Improved Oral Feeding and Prognosis by Promoting Neurodevelopment. Am J Perinatol. 2020 May;37(6):626-632. doi: 10.1055/s-0039-1685448. Epub 2019 Apr 23.

  PMID: 31013539 RESULT

• 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 RESULT

Related Links

• Oral motor intervention improved the oral feeding in preterm infants: Evidence based on a meta-analysis with trial sequential analysis.
• Effect of the premature infant oral motor intervention on feeding progression and length of stay in preterm infants.
• Establishing intervention fidelity of an oral motor intervention for preterm infants.
• Incidence of nasogastric and gastrostomy tube at discharge is reduced after implementing an oral feeding protocol in preterm (\<30 weeks) infants.
• Early premature infant Oral motor intervention improved oral feeding and prognosis by promoting neurodevelopment.

MeSH Terms

Conditions

Feeding Behavior; Premature Birth; Sucking Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Selver GÜLER, PhD

  https://www.hku.edu.tr/

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The PIOMI was applied only by the trained researcher, and blind to the nursing staff in charge of care and feeding. No information about the PIOMI was shared with the general staff working in the NICU, and it was performed in the absence of the mothers, although no formal curtain was used for additional blinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Asst.Prof.

Model Details: Sample The sample consisted of a total of 60 preterm infants all born after 26 weeks PMA with 30 each in the experimental and control group. Subjects were enrolled when they reached 29 or 30 weeks PMA and met inclusion criteria, and whose parents gave written consent. Random assignment to groups was performed by a research assistant, who was not involved in the research but worked in the same unit as the researchers, using the online software at https://www.randomizer.org. The primary nurses were blinded to groups, and the parents stepped out during therapy to assist in blinding.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: June 15, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)