Trial · NCT07883707
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study Feasibility and Acceptability Rates | From screening through NICU discharge (up to 6 weeks after enrollment). | Composite measure of study feasibility evaluated by overall eligibility rate, recruitment rate, enrollment rate, retention rate, and intervention protocol completion rate. |
| Primary | Infant Short-Term Heart Rate Response Across Intervention Sessions | Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment) | Change in mean heart rate in beats per minute (bpm) and variability (coefficient of variation) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention. |
| Primary | Infant Short-Term Respiratory Rate Response Across Intervention Sessions | Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment) | Change in mean respiratory rate (breaths per minute) and variability (coefficient of variation) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention. |
| Primary | Infant Short-Term Oxygen Saturation Response Across Intervention Sessions | Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment) | Change in mean oxygen saturation (SpO2) percentage and variability (coefficient of variation) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention. |
| Primary | Infant Short-Term Heart Rate Variability (High-Frequency HRV) Across PEOE Intervention Sessions | Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment) | Change in high-frequency heart rate variability (HF-HRV in ms2) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention. |
| Primary | Infant Short-Term Heart Rate Variability (SD12 Ratio) Across Intervention Sessions | Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment) | Change in Poincare nonlinear ratio (SD12) measured from pre-feeding baseline (30 minutes prior) to during the PEOE intervention session and 30 minutes post-intervention. |
| Primary | Infant Heart Rate Response During Feeding Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment) | Change in mean heart rate (bpm) and variability (coefficient of variation) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding. |
| Primary | Infant Respiratory Rate Response During Feeding Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment) | Change in mean respiratory rate (breaths per minute) and variability (coefficient of variation) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding. |
| Primary | Infant Oxygen Saturation Response During Feeding Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment) | Change in mean oxygen saturation (SpO2) percentage and variability (coefficient of variation) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding. |
| Primary | Infant Heart Rate Variability (High-Frequency HRV) During Feeding Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment). | Change in high-frequency heart rate variability (HF-HRV in ms2) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding. |
| Primary | Infant Heart Rate Variability (SD12 Ratio) During Feeding Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment). | Change in Poincare nonlinear ratio (SD12) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding. |
| Primary | Infant Splanchnic-to-Cerebral Oxygenation Ratio Pre- to Post-Feeding Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment). | Change in splanchnic-to-cerebral oxygen ratio (SOCR) measured via near-infrared spectroscopy (NIRS) from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding. |
| Primary | Infant Behavioral Feeding Regulation Near Discharge | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment) | Infant overall behavioral feeding skill evaluated during a single discharge feeding observation using the Early Feeding Skills (EFS) assessment tool total score (score range 19-57, higher scores indicate greater feeding skill and regulation). |
| Primary | Parental Depressive Symptoms Score | At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment) | Parental depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS) total score (range 0-30, higher scores indicate greater depressive symptoms). |
| Primary | Parental Anxiety State Score | At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment) | Parental anxiety symptoms assessed using the State-Trait Anxiety Inventory-Short Form (STAI-SF) total score (range 20-80, higher scores indicate higher anxiety). |
| Primary | Parental NICU Stress Score | At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment) | Parental stress resulting from the NICU environment assessed using the Parental Stressor Scale: NICU (PSS:NICU) total metric score (range 1-5, higher scores indicate greater stress). |
| Primary | Parenting Self-Efficacy | At enrollment and at discharge (up to 6 weeks post-enrollment) | Task-specific parenting confidence score evaluated using the Karitane Parenting Confidence Scale (KPCS; score range 0 to 45, with higher scores indicating greater confidence). |
| Secondary | Parent Feeding Co-Regulation Skill Score | Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment) | Parent responsive feeding co-regulation capability assessed via videotaped discharge feeding observations using the Dynamic-Early Feeding Skills (D-EFS) Caregiver Feeding Action subscale. Calculated as the percentage of total feeding duration that the parent spends engaged in responsive co-regulation behaviors (range 0% to 100% of feeding time, where a higher percentage indicates greater parent co-regulatory skill and responsiveness). |
| Secondary | Length of NICU Hospital Stay | From enrollment through NICU discharge (up to 8 weeks post-enrollment) | Total length of hospital stay measured in cumulative days from infant birth through final NICU discharge (extracted from electronic health records). |
| Secondary | Time to Achieve Full Oral Feeding | From enrollment through NICU discharge (up to 8 weeks post-enrollment) | Number of days required from study enrollment for the infant to achieve full oral feeding, defined as consuming 100% of daily enteral nutrition by mouth for at least 48 consecutive hours (extracted from electronic health records). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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