Feeding and Sucking in Preterm Infants

NCT04751903 | Completed DMC

• 1 other identifier: 216S081
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking.

Conditions

Preterm Birth Complication; Breast Feeding

Keywords

Feeding; Sucking success; Oral motor stimulation; Preterm infant

Outcome Measures

Primary Outcomes (4)

• LATCH Breastfeeding Assessment Tool

  It was developed by Jensen, Wallace, \& Kelsay (1994). Demirhan (1997) conducted its Turkey validity test and revealed that it is a reliable and easy-to-use scale. Each criterion is rated in the point range of 0-2 points. Breastfeeding is then assessed based on the sum of these scores. The highest and lowest scores of the tool are 10 and 0, respectively, and higher scores signify breastfeeding/sucking success.

  36th gestational week , 5 minute

• body weight

  The baby's body weight is weighed in grams with a digital scale.

  36th gestational week ,3 minute

• length

  The baby's length is measured in cm with a tape measure.

  36th gestational week,1 minute

• head circumference

  The baby's head circumference is measured in cm with a tape measure.

  36th gestational week ,1 minute

Study Arms (2)

Oral motor stimulation

EXPERIMENTAL

After the infants were assessed by a neonatologist, Oral motor stimulation was administered to the experimental group thrice a day (at 9:00, 12:00, 15:00 hours) for 15 minutes right before feeding, over a 14-day period.

Behavioral: oral motor stimulation

Control group

NO INTERVENTION

The preterm infant' the control group were only fed by the researcher thrice a day (at 9:00, 12:00, 15:00 hours) over a 14-day period.

Interventions

oral motor stimulation BEHAVIORAL

Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions.It took 15 minutes to apply the OMS by lightly touching their cheeks, lips, gums, and tongue with fingertips for the first 12 minutes, followed by letting the infant suck on a pacifier for the remaining 3 minutes. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants.

Oral motor stimulation

Eligibility Criteria

• Age: 29 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born between 29th and 34th gestational weeks, based on the mother's last menstruation date,
• Percentile measurements consistent with their gestational week measurements,
• Stable vital signs,
• APGAR scores between 4 and 10 in the 1st and 5th minutes,
• Stable for 48 hours after having received mechanical ventilation and/or continuous positive airway pressure,
• Being breastfed,
• Mother's eagerness to breastfeed the infant,
• Voluntary participation of parents in the study.

You may not qualify if:

• Suffered from severe asphyxia,
• Born with a low birth weight according to gestational week,
• Have intraventricular bleeding,
• With a congenital anomaly,
• Babies without their mother.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Bozoku

Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (4)

• Aguilar-Rodriguez M, Leon-Castro JC, Alvarez-Cerezo M, Aledon-Andujar N, Escrig-Fernandez R, Rodriguez de Dios-Benlloch JL, Hervas-Marin D, Vento-Torres M. The Effectiveness of an Oral Sensorimotor Stimulation Protocol for the Early Achievement of Exclusive Oral Feeding in Premature Infants. A Randomized, Controlled Trial. Phys Occup Ther Pediatr. 2020;40(4):371-383. doi: 10.1080/01942638.2019.1698688. Epub 2019 Dec 9.

  PMID: 31814522 BACKGROUND

• Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23.

  PMID: 24461572 BACKGROUND

• Coker-Bolt P, Jarrard C, Woodard F, Merrill P. The effects of oral motor stimulation on feeding behaviors of infants born with univentricle anatomy. J Pediatr Nurs. 2013 Jan;28(1):64-71. doi: 10.1016/j.pedn.2012.03.024. Epub 2012 Apr 10.

  PMID: 22497742 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

MeSH Terms

Conditions

Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayda ÇELEBİOĞLU, Prof.

  Mersin Univers

  PRINCIPAL INVESTIGATOR

• Kadir Şerafettin TEKGÜNDÜZ, Assoc. Prof

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study was conducted at neonatal intensive care unit (NICU) of the university hospital located in eastern Turkey between May 5th, 2017 and March 19th, 2018. The preterm infants were randomly allocated to two groups, experimental group and control group, by a computer-generated number table. The sample consisted of 77 preterm infants (39 in the experimental group and 38 in the control group) who met the inclusion criteria. The gestational weeks when babies are born were grouped as follows: 29-30 weeks, 31-32 weeks, and 33-34 weeks. In this study, only one researcher (1st author) who was not included in the intensive care team administered OMS to all the infants. Thus, the families and the NICU team were double-blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study was conducted as the randomized controlled and double-blind experimental trial. This study was guided by the CONSORT checklist

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: May 5, 2017
• Primary Completion: August 18, 2017
• Study Completion: March 19, 2018
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)