Premature BirthNCT07883707
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
A study testing Parent-Facilitated Early Oral-Sensory Experience (PEOE) in people with Premature Birth and Infant, Premature, run by Boston College.
Trial summary
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit (NICU). Read more about this study
- Who is it for?
- Ages 0 days to 32 weeks
- Conditions the study is for
- Premature Birth, Infant, Premature, Infant, Very Premature
- What is being tested?
- Parent-Facilitated Early Oral-Sensory Experience (PEOE)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Sep 2028
- 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 0 days to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very preterm infants born at less than 32 weeks gestational age
- Admitted to the Beth Israel Deaconess Medical Center (BIDMC) Neonatal Intensive Care Unit (NICU)
- Commenced or scheduled to commence enteral feedings
- Parent or legal guardian of an eligible infant
- Parent age 18 years or older
- Parent literate in English, Spanish, or Portuguese
- Parent available to participate in study data collection and/or intervention sessions
Who cannot join
- Born at 32 weeks gestational age or greater
- Presence of major congenital malformations of the mouth, face, or gastrointestinal tract
- Serious comorbidities that interfere with normal oral feeding development
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rachel Copertino, DNP, NNP-BC, IBCLC contact
About this study
Official title: Parent-Facilitated Early Oral-Sensory Experience Program: Enhancing NICU Outcomes Through a Family-Centered Feeding Approach
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit (NICU). Very preterm infants (born before 32 weeks gestational age) often face challenges developing oral feeding skills. The PEOE intervention involves training parents to deliver gentle, synchronized oral-sensory stimulation-such as placing small droplets of human milk in the infant's mouth paired with gentle touch, voice, and scent-starting immediately before gavage feedings and potentially continuing into the feeding. This study uses a sequential two-group design. The first group of parents and infants will receive usual NICU care. The second group will receive the PEOE intervention. Researchers will measure how feasible and acceptable the program is for parents and staff, infant physiological responses, feeding skill development, length of hospital stay, and parental emotional well-being.
- Conditions
- Premature Birth, Infant, Premature, Infant, Very Premature
- Being tested
- Parent-Facilitated Early Oral-Sensory Experience (PEOE)
- Keywords
- Oral-Sensory Experience, Early Oral Feeding, Neonatal Intensive Care Unit (NICU), Parent-Delivered Intervention, Multisensory Stimulation, Mother's Milk / Human Milk, Family-Centered Care, Very Preterm Infant, Gavage Feeding, Premature Infant Feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Facilitated Early Oral-Sensory Experience (PEOE)Behavioural
Parents administer small droplets of human milk (expressed breast milk or donor milk, up to 1 mL) orally via syringe, guided by infant readiness cues (e.g., mouthing, rooting). This is paired with synchronized multisensory stimulation (gentle touch, parental voice, parental scent, and taste/smell of milk). Sessions start immediately before gavage feedings and may continue into the feeding. Sessions occur in the incubator or during skin-to-skin care up to four times daily.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Parent-infant dyads receiving standard NICU care and standard enteral feeding without structured oral-sensory stimulation. |
| PEOE Intervention | Experimental | Parent-infant dyads receiving up to five individualized coaching sessions with a trained interventionist. Parents deliver the Parent-Facilitated Early Oral-Sensory Experience (PEOE) intervention independently during NICU visits up to four times daily before and/or during gavage feedings until oral feeding initiation. Receives: Behavioral: Parent-Facilitated Early Oral-Sensory Experience (PEOE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility and Acceptability Rates
Composite measure of study feasibility evaluated by overall eligibility rate, recruitment rate, enrollment rate, retention rate, and intervention protocol completion rate.
Measured: From screening through NICU discharge (up to 6 weeks after enrollment).
Infant Short-Term Heart Rate Response Across Intervention Sessions
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.
Measured: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Respiratory Rate Response Across Intervention Sessions
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.
Measured: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Oxygen Saturation Response Across Intervention Sessions
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.
Measured: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Heart Rate Variability (High-Frequency HRV) Across PEOE Intervention Sessions
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.
Measured: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Short-Term Heart Rate Variability (SD12 Ratio) Across Intervention Sessions
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.
Measured: Weekly from the first week of enteral feeding through oral feeding initiation (up to 6 weeks post-enrollment)
Infant Heart Rate Response During Feeding Near Discharge
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.
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Infant Respiratory Rate Response During Feeding Near Discharge
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.
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Infant Oxygen Saturation Response During Feeding Near Discharge
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.
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Infant Heart Rate Variability (High-Frequency HRV) During Feeding Near Discharge
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.
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment).
Infant Heart Rate Variability (SD12 Ratio) During Feeding Near Discharge
Change in Poincare nonlinear ratio (SD12) measured from 30 minutes pre-feeding baseline to during feeding and 30 minutes post-feeding.
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment).
Infant Splanchnic-to-Cerebral Oxygenation Ratio Pre- to Post-Feeding Near Discharge
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.
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment).
Infant Behavioral Feeding Regulation Near Discharge
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).
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Parental Depressive Symptoms Score
Parental depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS) total score (range 0-30, higher scores indicate greater depressive symptoms).
Measured: At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment)
Parental Anxiety State Score
Parental anxiety symptoms assessed using the State-Trait Anxiety Inventory-Short Form (STAI-SF) total score (range 20-80, higher scores indicate higher anxiety).
Measured: At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment)
Parental NICU Stress Score
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).
Measured: At enrollment, every 2 weeks during NICU hospitalization, and at NICU discharge (up to 6 weeks post-enrollment)
Parenting Self-Efficacy
Task-specific parenting confidence score evaluated using the Karitane Parenting Confidence Scale (KPCS; score range 0 to 45, with higher scores indicating greater confidence).
Measured: At enrollment and at discharge (up to 6 weeks post-enrollment)
Secondary outcomes (4)
Parent Feeding Co-Regulation Skill Score
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).
Measured: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Length of NICU Hospital Stay
Total length of hospital stay measured in cumulative days from infant birth through final NICU discharge (extracted from electronic health records).
Measured: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Time to Achieve Full Oral Feeding
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).
Measured: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Infant Weight Gain Velocity
Average infant weight gain velocity calculated in grams per kilogram per day (g/kg/day) from baseline enrollment to NICU discharge (extracted from electronic health records).
Measured: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Quasi-experimental sequential cohort study. Data collection will occur first on the usual care control cohort. Following the completion of control cohort data collection and nurse training in-services, data collection will occur on the intervention cohort receiving the PEOE protocol.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Beth Israel Deaconess Medical Center, Loyola University Chicago
- Responsible party
- Sponsor
- Investigators
- Jinhee Park, PhD, RN, FAAN, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883707
- Sponsor's protocol ID
- 2026P000621
- Other IDs
- R21HD119389
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Facilitated Early Oral-Sensory Experience Program: Enhancing NICU Outcomes Through a Family-Centered Feeding Approach
- ClinicalTrials.gov ID
- NCT07883707
- Acronym / sponsor ID
- 2026P000621
- Conditions
- Premature Birth, Infant, Premature, Infant, Very Premature
- Keywords
- Oral-Sensory Experience, Early Oral Feeding, Neonatal Intensive Care Unit (NICU), Parent-Delivered Intervention, Multisensory Stimulation, Mother's Milk / Human Milk, Family-Centered Care, Very Preterm Infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Beth Israel Deaconess Medical Center, Loyola University Chicago
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit (NICU). Very preterm infants (born before 32 weeks gestational age) often face challenges developing oral feeding skills. The PEOE intervention involves training parents to deliver gentle, synchronized oral-sensory stimulation-such as placing small droplets of human milk in the infant's mouth paired with gentle touch, voice, and scent-starting immediately before gavage feedings and potentially continuing into the feeding. This study uses a sequential two-group design. The first group of parents and infants will receive usual NICU care. The second group will receive the PEOE intervention. Researchers will measure how feasible and acceptable the program is for parents and staff, infant physiological responses, feeding skill development, length of hospital stay, and parental emotional well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Quasi-experimental sequential cohort study. Data collection will occur first on the usual care control cohort. Following the completion of control cohort data collection and nurse training in-services, data collection will occur on the intervention cohort receiving the PEOE protocol.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Parent-infant dyads receiving standard NICU care and standard enteral feeding without structured oral-sensory stimulation. |
| PEOE Intervention | Experimental | Behavioral: Parent-Facilitated Early Oral-Sensory Experience (PEOE)Parent-infant dyads receiving up to five individualized coaching sessions with a trained interventionist. Parents deliver the Parent-Facilitated Early Oral-Sensory Experience (PEOE) intervention independently during NICU visits up to four times daily before and/or during gavage feedings until oral feeding initiation. |
Who may qualify
- Ages
- 0 days to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Very preterm infants born at less than 32 weeks gestational age
- Admitted to the Beth Israel Deaconess Medical Center (BIDMC) Neonatal Intensive Care Unit (NICU)
- Commenced or scheduled to commence enteral feedings
- Parent or legal guardian of an eligible infant
- Parent age 18 years or older
Key exclusion criteria (3 listed)
- Born at 32 weeks gestational age or greater
- Presence of major congenital malformations of the mouth, face, or gastrointestinal tract
- Serious comorbidities that interfere with normal oral feeding development
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Facilitated Early Oral-Sensory Experience (PEOE)Parents administer small droplets of human milk (expressed breast milk or donor milk, up to 1 mL) orally via syringe, guided by infant readiness cues (e.g., mouthing, rooting). This is paired with synchronized multisensory stimulation (gentle touch, parental voice, parental scent, and taste/smell of milk). Sessions start immediately before gavage feedings and may continue into the feeding. Sessions occur in the incubator or during skin-to-skin care up to four times daily. | Behavioural | PEOE Intervention |
Primary outcome
Study Feasibility and Acceptability Rates
Time frame: 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.
Infant Short-Term Heart Rate Response Across Intervention Sessions
Time frame: 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.
Infant Short-Term Respiratory Rate Response Across Intervention Sessions
Time frame: 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.
Infant Short-Term Oxygen Saturation Response Across Intervention Sessions
Time frame: 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.
Infant Short-Term Heart Rate Variability (High-Frequency HRV) Across PEOE Intervention Sessions
Time frame: 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.
Infant Short-Term Heart Rate Variability (SD12 Ratio) Across Intervention Sessions
Time frame: 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.
Infant Heart Rate Response During Feeding Near Discharge
Time frame: 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.
Infant Respiratory Rate Response During Feeding Near Discharge
Time frame: 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.
Infant Oxygen Saturation Response During Feeding Near Discharge
Time frame: 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.
Infant Heart Rate Variability (High-Frequency HRV) During Feeding Near Discharge
Time frame: 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.
Infant Heart Rate Variability (SD12 Ratio) During Feeding Near Discharge
Time frame: 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.
Infant Splanchnic-to-Cerebral Oxygenation Ratio Pre- to Post-Feeding Near Discharge
Time frame: 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.
Infant Behavioral Feeding Regulation Near Discharge
Time frame: 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).
Parental Depressive Symptoms Score
Time frame: 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).
Parental Anxiety State Score
Time frame: 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).
Parental NICU Stress Score
Time frame: 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).
Parenting Self-Efficacy
Time frame: 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).
4 secondary outcomes
Parent Feeding Co-Regulation Skill Score
Time frame: Assessed during a single feeding observation during the discharge week (approximately 2 to 6 weeks post-enrollment)
Length of NICU Hospital Stay
Time frame: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Time to Achieve Full Oral Feeding
Time frame: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Infant Weight Gain Velocity
Time frame: From enrollment through NICU discharge (up to 8 weeks post-enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Copertino, DNP, NNP-BC, IBCLC contact
Jinhee Park, PhD, RN, FAAN principal investigator
Boston College
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Facilitated Early Oral-Sensory Experience (PEOE) in people with Premature Birth and Infant, Premature, run by Boston College.
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 3 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 20 Oct 2026. 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 Jinhee Park, PhD, RN, FAAN (617-552-6542, jinhee.park@bc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility and Acceptability Rates (time frame: From screening through NICU discharge (up to 6 weeks after enrollment).). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.