Clinical trial NCT06763497: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Congenital Heart Disease
Oral Feeding
Systematic Health Education Program
Feeding Difficulties
Parenting Stress
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

1. 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.
2. 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.

Primary outcomes:
measure: oral feeding techniques scale for primary caregivers early feeding skills assessment EFS parenting stress index, fourth edition short form, PSI-4-SF
timeFrame: on the 14th day
measure: early feeding skills assessment, EFS
timeFrame: on the 14th day
measure: parenting stress index, fourth edition short form, PSI-4-SF
timeFrame: on the 14th day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: YA-HAN LIN, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hasenstab KA, Jadcherla SR. Evidence-Based Approaches to Successful Oral Feeding in Infants with Feeding Difficulties. Clin Perinatol. 2022 Jun;49(2):503-520. doi: 10.1016/j.clp.2022.02.004.
citation: Hewitt-Taylor J. Clinical guidelines and care protocols. Intensive Crit Care Nurs. 2004 Feb;20(1):45-52. doi: 10.1016/j.iccn.2003.08.002.
citation: Holst LM, Serrano F, Shekerdemian L, Ravn HB, Guffey D, Ghanayem NS, Monteiro S. Impact of feeding mode on neurodevelopmental outcome in infants and children with congenital heart disease. Congenit Heart Dis. 2019 Nov;14(6):1207-1213. doi: 10.1111/chd.12827. Epub 2019 Aug 2.
citation: Horsley M, Hill GD, Kaskie S, Schnautz M, Brown J, Marcuccio E. Evaluation of an Outpatient and Telehealth Initiative to Reduce Tube Dependency in Infants with Complex Congenital Heart Disease. Pediatr Cardiol. 2022 Oct;43(7):1429-1437. doi: 10.1007/s00246-022-02864-6. Epub 2022 Mar 25.
citation: Indramohan G, Pedigo TP, Rostoker N, Cambare M, Grogan T, Federman MD. Identification of Risk Factors for Poor Feeding in Infants with Congenital Heart Disease and a Novel Approach to Improve Oral Feeding. J Pediatr Nurs. 2017 Jul-Aug;35:149-154. doi: 10.1016/j.pedn.2017.01.009. Epub 2017 Feb 4.
citation: Jones CE, Desai H, Fogel JL, Negrin KA, Torzone A, Willette S, Fridgen JL, Doody LR, Morris K, Engstler K, Slater NL, Medoff-Cooper B, Smith J, Harris BD, Butler SC. Disruptions in the development of feeding for infants with congenital heart disease. Cardiol Young. 2021 Apr;31(4):589-596. doi: 10.1017/S1047951120004382. Epub 2020 Dec 11.
citation: Jones C, Winder M, Ou Z, Miller TA, Malik L, Flannery M, Glotzbach K. Feeding outcomes in post-discharge feeding clinic for infants following cardiac surgery. Cardiol Young. 2022 Apr;32(4):628-635. doi: 10.1017/S1047951121002833. Epub 2021 Jul 26.
citation: Kamran, F., Sagheb, S., Khatoonabadi, S. A., Ebadi, A., Faryadras, Y., & Aghajanzadeh, M. (2021). The Validity and Reliability of Early Feeding Skills Assessment and Cue-Based Feeding Scales for Preterm Infants. Middle East Journal of Rehabilitation and Health Studies, 8(3). https://doi.org/10.5812/mejrh.110973
citation: Kotowski J, Fowler C, Hourigan C, Orr F. Bottle-feeding an infant feeding modality: An integrative literature review. Matern Child Nutr. 2020 Apr;16(2):e12939. doi: 10.1111/mcn.12939. Epub 2020 Jan 6.
citation: Krom H, de Winter JP, Kindermann A. Development, prevention, and treatment of feeding tube dependency. Eur J Pediatr. 2017 Jun;176(6):683-688. doi: 10.1007/s00431-017-2908-x. Epub 2017 Apr 13.
citation: Lau C, Geddes D, Mizuno K, Schaal B. The development of oral feeding skills in infants. Int J Pediatr. 2012;2012:572341. doi: 10.1155/2012/572341. Epub 2012 Nov 5. No abstract available.
citation: Mahoney AS, O'Donnell M, Coyle JL, Turner R, White KE, Skoretz SA. Non-Pharmacological and Non-Surgical Feeding Interventions for Hospitalized Infants with Pediatric Feeding Disorder: A Scoping Review. Dysphagia. 2023 Jun;38(3):818-836. doi: 10.1007/s00455-022-10504-7. Epub 2022 Aug 31.
citation: Manno, C. J., Fox, C., Eicher, P. S., & Kerwin, M. E. (2005). Early oral-motor interventions for pediatric feeding problems: What, when and how. Journal of Early and Intensive Behavior Intervention, 2(3), 145. https://doi.org/10.1037/h0100310
citation: Martini S, Beghetti I, Annunziata M, Aceti A, Galletti S, Ragni L, Donti A, Corvaglia L. Enteral Nutrition in Term Infants with Congenital Heart Disease: Knowledge Gaps and Future Directions to Improve Clinical Practice. Nutrients. 2021 Mar 13;13(3):932. doi: 10.3390/nu13030932.
citation: Medoff-Cooper B, Irving SY, Hanlon AL, Golfenshtein N, Radcliffe J, Stallings VA, Marino BS, Ravishankar C. The Association among Feeding Mode, Growth, and Developmental Outcomes in Infants with Complex Congenital Heart Disease at 6 and 12 Months of Age. J Pediatr. 2016 Feb;169:154-9.e1. doi: 10.1016/j.jpeds.2015.10.017. Epub 2015 Nov 13.
citation: Morag I, Hendel Y, Karol D, Geva R, Tzipi S. Transition From Nasogastric Tube to Oral Feeding: The Role of Parental Guided Responsive Feeding. Front Pediatr. 2019 May 9;7:190. doi: 10.3389/fped.2019.00190. eCollection 2019.
citation: Neto, F., França, A. P., & Cruz, S. (2016). An algorithm proposal to oral feeding in premature infants. The European Procedings of Social Behavioural Sciences, 87-98. https://doi.org/10.15405/epsbs.2016.07.02.8
citation: Philbin MK, Ross ES. The SOFFI Reference Guide: text, algorithms, and appendices: a manualized method for quality bottle-feedings. J Perinat Neonatal Nurs. 2011 Oct-Dec;25(4):360-80. doi: 10.1097/JPN.0b013e31823529da.
citation: Ross ES, Browne JV. Developmental progression of feeding skills: an approach to supporting feeding in preterm infants. Semin Neonatol. 2002 Dec;7(6):469-75. doi: 10.1053/siny.2002.0152.
citation: Ross ES, Philbin MK. Supporting oral feeding in fragile infants: an evidence-based method for quality bottle-feedings of preterm, ill, and fragile infants. J Perinat Neonatal Nurs. 2011 Oct-Dec;25(4):349-57; quiz 358-9. doi: 10.1097/JPN.0b013e318234ac7a.
citation: Slater, N., Spader, M., Fridgen, J., Horsley, M., Davis, M., & Griffin, K. H. (2021). Weaning from a feeding tube in children with congenital heart disease: A review of the literature. Progress in Pediatric Cardiology, 62, 101406. https://doi.org/10.1016/j.ppedcard.2021.101406
citation: Thoyre SM, Hubbard C, Park J, Pridham K, McKechnie A. Implementing Co-Regulated Feeding with Mothers of Preterm Infants. MCN Am J Matern Child Nurs. 2016 Jul/Aug;41(4):204-211. doi: 10.1097/NMC.0000000000000245.
citation: Thoyre SM, Pados BF, Shaker CS, Fuller K, Park J. Psychometric Properties of the Early Feeding Skills Assessment Tool. Adv Neonatal Care. 2018 Oct;18(5):E13-E23. doi: 10.1097/ANC.0000000000000537.
citation: Thoyre SM, Shaker CS, Pridham KF. The early feeding skills assessment for preterm infants. Neonatal Netw. 2005 May-Jun;24(3):7-16. doi: 10.1891/0730-0832.24.3.7.
citation: Ubeda Tikkanen A, Vova J, Holman L, Chrisman M, Clarkson K, Santiago R, Schonberger L, White K, Badaly D, Gauthier N, Pham TDN, Britt JJ, Crouter SE, Giangregorio M, Nathan M, Akamagwuna UO. Core components of a rehabilitation program in pediatric cardiac disease. Front Pediatr. 2023 May 31;11:1104794. doi: 10.3389/fped.2023.1104794. eCollection 2023.
citation: White, A., & Parnell, K. (2013). The transition from tube to full oral feeding (breast or bottle)-A cue-based developmental approach. Journal of Neonatal Nursing, 19(4), 189-197. https://doi.org/10.1016/j.jnn.2013.03.006
citation: Willson, L., & Spence, K. (2022). Development of a Foundation Protocol for Feeding Complex Care Neonates and Enablers and Barriers to Its Implementation. Comprehensive Child and Adolescent Nursing, 45(3), 331-344. https://doi.org/10.1080/24694193.2022.2053613