The Effect of The Premature Infant Oral Motorınterventıon on Suckıng Capacıty in Preterm Infants
Condition: Feeding Behavior; Premature Birth; Sucking Behavior
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Detailed description: 
      METHODS The data were obtained for 11 months between May 2019 and March 2020 in the NICUs of
      two different hospitals in the Gaziantep province of Turkey using a single-blind randomized
      controlled experimental design.

      Eligibilty was determined by the neonatologist based on the following inclusion criteria: 1)
      babies born at 26-30 weeks PMA, 2) stable clinical condition, 3) vital signs stable for at
      least 24 hours, 4) able to have PIOMI by the 29th or 30th week PMA, 5) required respiratory
      support limited to an oxyhood, Continuous Positive Airway Pressure (CPAP) and/or nasal
      cannula up to 2L flow, 6) APGAR scores at 1- and 5-minutes of 4 and above, 7) any race or
      ethnicity, 8) intraventricular hemmorhage limited to level 1 or 2; and 9) had no birth
      defects including facial anomolies that would impact feeding.

      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.

      Two subjects were lost during the research period. Subject number 15 in the experimental
      group died on the 11th day after enrollment of causes unrelated to the intervention. Subject
      number 31 in the control group was intubated on the 7th day after enrollment thus became
      ineligable. After a subject dropped out, the next subject enrolled replaced that subject and
      the study was continued with the same sample size.

      Data Collection Tools The data were recorded on a Data Collection Form, a Follow-up Form for
      Daily Procedures Applied to the Infant, a Sucking Capacity Monitoring Form. The outcome
      measurements required preterm baby bottles and pacifiers, measuring tape for growth
      measurements, a scale, a bottle and pacifier sterilization machine, a labeling machine, and
      preterm baby silicone bottle nipples. Sucking capacity was measured by the Yakut Manometer
      Measuring Suction Power (Figure 1), a pressure manometer embedded into a silicone nipple
      developed specifically for this study by Prof. Dr. Yavuz Yakut (International Patent Number
      PCT/TR2019/050678). The PIOMI intervention required a stopwatch and infant monitors and no
      other equipment.

      Ethical Approval Approval for this research was obtained and dated 9.03.2019 from Hasan
      Kalyoncu University Faculty of Health Sciences, Research Ethics Committee(2019/29). To ensure
      correct performance of the PIOMI, the researcher trained with Dr. Brenda Lessen Knoll, the
      founder of PIOMI, and competency was evaluated via review of a video-recording of the
      researcher doing PIOMI on a preterm baby (with written consent from the parents) using the
      Reliability Rating Tool (13) to ensure intervention fidelity. Written permission was received
      from Dr. Yakut to use his manometer for measuring sucking power in this study. Written
      informed consent was obtained from the parents of all subjects.

      Test-Retest Reliability of the Manometer Measuring Suction Power To asses the reliability of
      the newly developed Yakut Manometer Measuring Suction Power it was tested on 10 preterm
      babies who had transitioned to full oral feedings and who had written consent from the
      parents and who were approved by a neonatologist. Each baby sucked on the manometer nipple
      for a minimum of one minute of successful sucking on two separate occcasions with a 5-minute
      interval in between. During both measurements, the highest value the infant could reach
      within the first minute after the baby began to suck was documented. The average sucking
      power at the 1st measure was 102±22.38 mmHg, and 104.5±13.83 mmHg at the 2nd measure. The
      test re-test reliability coefficient between the two applications was calculated by the
      Intraclass Correlation Coefficient (ICC) (2.1) and found to be 0.912. An ICC value of 0.75
      indicates good reliability, and above .90 is excellent (33). The obtained ICC value of above
      0.90 showed that the manometer was suitable / acceptable for use in clinical measurements
      (34).

      Application Phase 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. Day 1 of the study was
      considered the 1st day that the babies received PIOMI. The researcher applied PIOMI 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 both groups 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 (CONSORT Flow Diagram). A separate manometer nipple was used for each baby and
      labeled with names and surnames. Before each use, the bottle nipple was sterilized with a
      bottle and pacifier sterilization machine. Routine hand-washing was excercised before and
      after any patient or equipment contact. Babies were monitored during both the PIOMI
      application and the evaluation of the sucking capacity for any negative physiological/
      behavioral cues of intolerance (apnea, bradycardia, desaturation below 90%, crying,
      tachycardia, facial color change). If one negative cue was observed, the procedure was
      suspended until the baby returned to normal, and was documented. The intervention would then
      be conitnued the following day.
    

Intervention name(s): Premature Infant Oral Motor Intervention (PIOMI)
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Preterm Infant; Sucking Capacity; Premature Infant Oral Motor Intervention; Feeding; Oral Stimulation