The Efficacy of Systematic Oral Feeding Education Program

NCT06763497 | Not Yet Recruiting

• 1 other identifier: 202412004RINA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

After the intervention of Systematic Oral Feeding Education Program:

1. 1.The feeding techniques scores of the main caregivers in the experimental group will be higher than those in the control group.
2. 2.The caregiving stress scores of the main caregivers in the experimental group will be lower than those in the control group.
3. 3.The feeding skill scores of infants in the experimental group will be higher than those in the control group.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; Oral Feeding; Systematic Health Education Program; Feeding Difficulties; Parenting Stress

Outcome Measures

Primary Outcomes (3)

• oral feeding techniques scale for primary caregivers early feeding skills assessment EFS parenting stress index, fourth edition short form, PSI-4-SF

  The researcher developed a self-designed scale based on systematic oral feeding education program, expert opinions, and relevant literature to evaluate the primary caregiver's oral feeding techniques. The scale comprises four main sections: 1. Preparation before feeding (including oral stimulation). 2. Feeding process (including oral support). 3. Provision of developmental feeding support. 4. Observation of dehydration warning signs. The scale consists of 21 items. When the caregiver's feeding behavior or response aligns with the descriptions in the items, it is marked as "Yes" and awarded 1 point. If not, it is marked as "No" and receives 0 points. The total score ranges from 0 to 21, with higher scores indicating better feeding techniques. The evaluation is conducted by observing the caregiver during actual feeding sessions (or reviewing recorded feeding videos) and scoring based on their observed behaviors.

  on the 14th day

• early feeding skills assessment, EFS

  The EFS consists of 24 items that assess infant feeding skills across three domains: 1. Preparation for oral feeding (3 items: motor behavior, state, and oral behaviors when given a pacifier). 2. Feeding process evaluation, which des: breathing regulation (5 items), coordination of oral movements (4 items), swallowing coordination (4 items), sustaining engagement (2 items), and physiological stability (4 items). 3. Post-feeding tolerance (2 items: state and energy level). Each item is scored on a scale of 1 to 3, where a score of 1 indicates problems, and a score of 3 indicates no problems. The total score ranges from 24 to 72, with higher scores indicating better feeding skills. The assessment identifies both the infant's abilities and areas of difficulty.

  on the 14th day

• parenting stress index, fourth edition short form, PSI-4-SF

  This scale was originally developed to evaluate parenting stress in parents of children. Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) consists of 36 items selected from the Long Form and is divided into three subscales: 1. Parental Distress (Items 1-12): Assesses the distress experienced by individuals in their role as a parent. 2. Parent-Child Dysfunctional Interaction (Items 13-24): Evaluates stress arising from interactions and mutual influences between parents and children. 3. Difficult Child (Items 25-36): Assesses behavioral characteristics of the child that contribute to stress in the parent-child system. The scale uses a 5-point Likert scale for scoring, ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). The total score ranges from a minimum of 36 to a maximum of 180, with higher scores indicating greater levels of parenting stress.

  on the 14th day

Study Arms (2)

The control group - received routine care

NO INTERVENTION

On the day of receipt of the case, after completing the informed consent form, the pre-test was also completed, including asking the subjects to complete the "Basic Case Information Form" and the "Parenting Stress Scale", and the researcher observed the primary caregiver feeding the baby. , use the "Oral Feeding Techniques Scale" to evaluate the caregiver's feeding techniques and the "Infant Feeding Skills Assessment Scale" to evaluate the infant's oral feeding status. In addition, the subjects were asked to fill in the feeding record form every day during the 14-day period, and complete the aforementioned self-report scale and observation evaluation form on the day the case was closed. The control group received routine care in the ward and took the post-test of the scale on the 14th day.

experimental group - systematic oral feeding education program

OTHER

The experimental group conducted 11 interventions before and after completing the primary caregiver's oral feeding techniques, caregiving stress and infant feeding skills. The first time was after completing the pre-test, a systematic oral feeding education program was used to provide feeding skills guidance and Practical feeding guidance, and assisting in video recording during the actual feeding operation. After completion, the video was used to discuss possible corrections. The remaining 10 interventions were conducted on days 2-4, 6-9, and 11-13 to observe the main care every day. The patient's feeding status was reviewed once and assistance and suggestions were provided. On the 14th day, the patient completed the relevant scale post-test.

Other: Systematic Oral Feeding Education Program

Interventions

Systematic Oral Feeding Education Program OTHER

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.

experimental group - systematic oral feeding education program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Caregivers unable to complete self-administered questionnaires.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (35)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35659100 BACKGROUND

• 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.

  PMID: 14726253 BACKGROUND

• 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.

  PMID: 31373176 BACKGROUND

• 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.

  PMID: 35333946 BACKGROUND

• 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.

  PMID: 28169036 BACKGROUND

• 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.

  PMID: 33303052 BACKGROUND

• 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.

  PMID: 34304751 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31908144 BACKGROUND

• 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.

  PMID: 28409284 BACKGROUND

• 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.

  PMID: 23193413 BACKGROUND

• 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.

  PMID: 36044080 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33805775 BACKGROUND

• 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.

  PMID: 26585995 BACKGROUND

• 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.

  PMID: 31143759 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22071621 BACKGROUND

• 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.

  PMID: 12614599 BACKGROUND

• 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.

  PMID: 22071619 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27111440 BACKGROUND

• 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.

  PMID: 30239407 BACKGROUND

• 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.

  PMID: 15960007 BACKGROUND

• 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.

  PMID: 37334215 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Related Links

• American Heart Association. (n.d.). The Impact of Congenital Heart Defects.
• Thoyre, S. (2021). Early Feeding Skills Assessment Tool (EFS). Retrieved from Feeding Flock.

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• YA-HAN LIN, MS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YA-HAN LIN, MS

CONTACT

+886926160252; yahanlin@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share