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Congenital Heart DiseaseSOFEPNCT06763497

The Efficacy of Systematic Oral Feeding Education Program

A study testing Systematic Oral Feeding Education Program in people with Congenital Heart Disease, run by National Taiwan University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Congenital Heart Disease
What is being tested?
Systematic Oral Feeding Education Program
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 19 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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 unable to complete self-administered questionnaires.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

YA-HAN LIN, MS contact

+886926160252

yahanlin@ntuh.gov.tw

About this study

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

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.
Read the 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.

Being tested
Systematic Oral Feeding Education Program
Keywords
Congenital Heart Disease, Oral Feeding, Systematic Health Education Program, Feeding Difficulties, Parenting Stress
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systematic Oral Feeding Education ProgramOther

    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.

Study groups in NCT06763497
Study groupRoleWhat they receive
The control group - received routine careNo interventionOn 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 programOtherThe 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.
Receives: Other: Systematic Oral Feeding Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: on the 14th day

  2. 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.

    Measured: on the 14th day

  3. 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.

    Measured: on the 14th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion19 Dec 2025 (estimated)
  4. Study completion19 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763497
Sponsor's protocol ID
202412004RINA
Acronym
SOFEP
Status last verified
Dec 2024
First submitted
1 Jan 2025
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27644167

  • 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.

    PubMed 35659100

  • 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.

    PubMed 14726253

  • 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.

    PubMed 31373176

  • 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.

    PubMed 35333946

  • 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.

    PubMed 28169036

  • 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.

    PubMed 33303052

  • 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.

    PubMed 34304751

Questions about this trial

What is this clinical trial studying?

A study testing Systematic Oral Feeding Education Program in people with Congenital Heart Disease, run by National Taiwan University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact YA-HAN LIN, MS (+886926160252, yahanlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763497, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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