The Efficacy of Systematic Oral Feeding Education Program

Official title

The Efficacy of Systematic Oral Feeding Education Program (SOFEP) on Feeding Techniques, Caregiver Stress, and Infant Feeding Skills in Caregivers of Infants With Congenital Heart Disease After Surgery

Overview

After the intervention of Systematic Oral Feeding Education Program: 1. The feeding techniques scores of the main caregivers in the experimental group will be higher than those in the control group. 2. The caregiving stress scores of the main caregivers in the experimental group will be lower than those in the control group. 3. The feeding skill scores of infants in the experimental group will be higher than those in the control group.

Detailed description

This study will adopt a quasi-experimental design and will purposively and consecutively sample participants from the pediatric ward of a medical center in northern Taiwan. Enrollment will be conducted based on the inclusion and exclusion criteria of the study. To avoid contamination between the experimental and control groups, recruitment for the control group will be completed before recruitment for the experimental group begins. Each group will undergo a 3-month recruitment period or until 30 participants have been enrolled in each group.

Each participant will be followed for 14 days. On the enrollment day, after obtaining informed consent, a pretest will be conducted. This includes completing the "Participant Demographic Information Form" and the "Parenting Stress Index" and having the primary caregiver's infant feeding practices observed by the researcher. The caregiver's feeding techniques will be assessed using the "Oral Feeding Techniques Scale," and the infant's oral feeding performance will be evaluated using the "Early Feeding Skills Assessment Scale." Additionally, participants will complete a daily feeding log for the 14-day study period. On the final day, posttests will include the same self-reported questionnaires and observation-based assessments as the pretest.

The control group will receive standard ward care and will complete the posttest on the 14th day. The experimental group will receive 11 intervention sessions during the study period. The first intervention will occur immediately after the pretest and will involve a systematic oral feeding education program, including guided feeding techniques and practical feeding demonstrations. During the feeding session, caregivers' practices will be recorded on video. These recordings will then be reviewed with the caregiver to identify areas for improvement.

The remaining 10 intervention sessions will take place daily on days 2-4, 6-9, and 11-13, during which the researcher will observe the primary caregiver's feeding practices, provide assistance, and offer tailored suggestions. On the 14th day, the experimental group will complete the same posttest assessments as the control group.

Statistical analysis will be conducted using SPSS Statistics (version 22.0). Independent sample t-tests, paired sample t-tests, and generalized estimating equations (GEE) will be employed to evaluate the effects of the systematic oral feeding education program on the primary caregiver's feeding techniques, caregiving stress, and the infant's oral feeding skills.

Interventions

• Other Systematic Oral Feeding Education Program
  The experimental group will receive 11 intervention sessions during the study period. The first intervention will occur immediately after the pretest and will involve a systematic oral feeding education program, including guided feeding techniques and practical feeding demonstrations. During the feeding session, caregivers' practices will be recorded on video. These recordings will then be reviewed with the caregiver to identify areas for improvement.The remaining 10 intervention sessions will t

Primary outcome measures

• oral feeding techniques scale for primary caregivers early feeding skills assessment EFS parenting stress index, fourth edition short form, PSI-4-SF [Time frame: on the 14th day]
• early feeding skills assessment, EFS [Time frame: on the 14th day]
• parenting stress index, fourth edition short form, PSI-4-SF [Time frame: on the 14th day]

Eligibility criteria

Infants with congenital heart disease and their primary caregivers who meet the following conditions will be admitted:

• Infant Criteria:

Inclusion criteria

• Infants diagnosed with congenital heart disease and younger than 12 months at the time of enrollment.
• Infants unable to meet their required oral feeding volume (10% of body weight = 100 ml/kg) at the time caregiving begins.
• Infants who have undergone open-heart surgery with cardiopulmonary bypass.
• Infants assessed by physicians as ready to begin oral feeding training.

Exclusion criteria

• Corrected gestational age less than 32 weeks.
• Infants with congenital conditions involving the mouth, throat, or esophagus (e.g., cleft palate, esophageal atresia with tracheoesophageal fistula).
• Infants with congenital central nervous system disorders.
• Infants consuming food via methods other than bottle feeding (e.g., spoon-feeding, complementary food, or solid food).
• Infants whose primary feeding method is breastfeeding directly at the breast.
• Primary Caregiver Criteria

Inclusion criteria

• Caregivers aged 18 years or older.
• The infant's legal father or mother.
• Caregivers who participate in at least two oral feeding sessions per day for the infant.

Exclusion criteria

• Caregivers unable to complete self-administered questionnaires.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Bala P, Kaur R, Mukhopadhyay K, Kaur S. Oromotor Stimulation for Transition from Gavage to Full Oral Feeding in Preterm Neonates: A Randomized controlled trial. Indian Pediatr. 2016 Jan;53(1):36-8. doi: 10.1007/s13312-016-0786-3. PMID 26840669
• Desai, H., & Lim, A. N. (2019). Neurodevelopmental intervention strategies to improve oral feeding skills in infants with congenital heart defects. Perspectives of the ASHA Special Interest Groups, 4(6), 1492-1497.
• Desai H, Jones CE, Fogel JL, Negrin KA, Slater NL, Morris K, Doody LR, Engstler K, Torzone A, Smith J, Butler SC. Assessment and management of feeding difficulties for infants with complex CHD. Cardiol Young. 2023 Jan;33(1):1-10. doi: 10.1017/S1047951122004024. Epub 2022 Dec 23. PMID 36562257
• Fucile S, Dow K. A Unique Clinical Tool for the Evaluation of Oral Feeding Skills in Infants. Can J Occup Ther. 2023 Sep;90(3):240-248. doi: 10.1177/00084174221134738. Epub 2022 Oct 30. PMID 36314405
• 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
• Goday PS, Huh SY, Silverman A, Lukens CT, Dodrill P, Cohen SS, Delaney AL, Feuling MB, Noel RJ, Gisel E, Kenzer A, Kessler DB, Kraus de Camargo O, Browne J, Phalen JA. Pediatric Feeding Disorder: Consensus Definition and Conceptual Framework. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):124-129. doi: 10.1097/MPG.0000000000002188. PMID 30358739
• Goldstein SA, Watkins KJ, Lowery RE, Yu S, Knight RM, Drayton AK, Sayers L, Gaies M. Oral Aversion in Infants With Congenital Heart Disease: A Single-Center Retrospective Cohort Study. Pediatr Crit Care Med. 2022 Mar 1;23(3):e171-e179. doi: 10.1097/PCC.0000000000002879. PMID 34991136
• Greene Z, O'Donnell CP, Walshe M. Oral stimulation for promoting oral feeding in preterm infants. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009720. doi: 10.1002/14651858.CD009720.pub2. PMID 27644167

Identifiers

NCT: NCT06763497 · 202412004RINA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗