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NCT Number: NCT06763497

The Efficacy of Systematic Oral Feeding Education Program

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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 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:
- Preparation before feeding (including oral stimulation).
- Feeding process (including oral support).
- Provision of developmental feeding support.
- 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.
early feeding skills assessment, EFS

Time frame: on the 14th day
The EFS consists of 24 items that assess infant feeding skills across three domains:
- Preparation for oral feeding (3 items: motor behavior, state, and oral behaviors when given a pacifier).
- 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).
- 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.
parenting stress index, fourth edition short form, PSI-4-SF

Time frame: on the 14th day
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:
- Parental Distress (Items 1-12): Assesses the distress experienced by individuals in their role as a parent.
- Parent-Child Dysfunctional Interaction (Items 13-24): Evaluates stress arising from interactions and mutual influences between parents and children.
- 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.

Study contacts

Contact information is provided by the study sponsor or research team.

YA-HAN LIN, MS

CONTACT

[email protected]

+886926160252

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Acronym: SOFEP

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 8, 2025
Registry last updated: Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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