Infant Admitted to Neonatal Intensive Care Unit (NICU)NCT07789145
The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit
A study testing Reading Intervention in people with Infant Admitted to Neonatal Intensive Care Unit (NICU), run by University of Texas Southwestern Medical Center.
Trial summary
The purpose of this study is to investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and following discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant Admitted to Neonatal Intensive Care Unit (NICU)
- What is being tested?
- Reading Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2026to 15 Jan 2029
- 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
- the infant must have a NICU LOS > 3 days;
- a dedicated caregiver, such as parent, relative, friend of the family, grandparent are present in NICU;
- the primary caregiver can read and speak in English.
Who cannot join
- Infants with a confirmed diagnosis of hearing loss will be excluded from the study, as the intervention is based on auditory stimulation through shared reading;
- the caregiver has cognitive impairments or under legal guardianship;
- the caregiver is unable to speak;
- the infant is under foster care at the time of enrollment.
About this study
The purpose of this study is to investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and following discharge. The specific aims are:
Aim 1: To evaluate the primary outcome of infant physiological response, including heart rate, respiratory rate, and oxygen saturation, when read by their caregiver. Infant heart rate, respiratory rate and oxygen saturations (SpO2) will be measured 15 minutes prior to the intervention, at start of the intervention, 2 minutes into the intervention, and 15 minutes after the intervention is completed. Outcomes will be compared to those of a control group.
Aim 2: To explore the secondary outcome of the intervention effect on maternal mental health, as measured by changes in postpartum depression (PPD) scores.
- Being tested
- Reading Intervention
- Keywords
- neonatal intensive care unit, NICU, postpartum depression, dyadic intervention, reading to infant, EPDS, infant, neonate, postpartum, mother, caregiver, Edinburgh Postnatal Depression Scale
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading InterventionBehavioural
The intervention consists of the following content:
- Handouts explaining the benefits of reading to your infant will be provided and discussed at the time of enrollment.
- Instructions outlining that a minimum of 3 reading sessions, lasting at least 2 minutes, should be provided to the infant, and how to log the reading sessions.
- Information on how to obtain books from the NICU library if choosing to utilize that resource. Parents will be informed that they can bring in their own books from home should they want to.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Experimental | Receive additional information on the benefits of reading to your infant. They will be instructed to participate in a minimum of 3 structured reading sessions and how to log each session. Receives: Behavioral: Reading Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infant heart rate
Heart rate, will be abstracted from medical record review. Heart rate will be measured by the number of beats the infant's heart has per minute.
Measured: Baseline (at start of the intervention), 2 minutes into the intervention
Change in Infant heart rate
Heart rate, will be abstracted from medical record review. Heart rate will be measured by the number of beats the infant's heart has per minute.
Measured: Baseline (at start of the intervention),15 minutes after the intervention
Change in Infant Respiratory rate
Respiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Measured: Baseline (at start of the intervention), 2 minutes into the intervention
Change in Infant Respiratory rate
Respiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Measured: Baseline (at start of the intervention), 15 minutes after the intervention
Change in Infant Oxygen saturation level
Oxygen saturations level will be abstracted from medical record review. Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
Measured: Baseline (at start of the intervention), 2 minutes into the intervention
Change in Infant Oxygen saturation level
Oxygen saturations level will be abstracted from medical record review. Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
Measured: Baseline (at start of the intervention), 15 minutes after the intervention
Secondary outcomes (1)
Caregiver Outcome
Qualifying mothers will have their incidence of postpartum depression assessed through the self-reporting EPDS tool.
Measured: Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start14 Sep 2026 (estimated)
- Primary completion14 Sep 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Admitted to Neonatal Intensive Care Unit (NICU)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carissa Gasparovic, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789145
- Sponsor's protocol ID
- STU20252355
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07789145
- Acronym / sponsor ID
- STU20252355
- Keywords
- neonatal intensive care unit, NICU, postpartum depression, dyadic intervention, reading to infant, EPDS, infant, neonate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 14 Sep 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 27 Aug 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 investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and following discharge. The specific aims are:
Aim 1: To evaluate the primary outcome of infant physiological response, including heart rate, respiratory rate, and oxygen saturation, when read by their caregiver. Infant heart rate, respiratory rate and oxygen saturations (SpO2) will be measured 15 minutes prior to the intervention, at start of the intervention, 2 minutes into the intervention, and 15 minutes after the intervention is completed. Outcomes will be compared to those of a control group.
Aim 2: To explore the secondary outcome of the intervention effect on maternal mental health, as measured by changes in postpartum depression (PPD) scores.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Experimental | Behavioral: Reading InterventionReceive additional information on the benefits of reading to your infant. They will be instructed to participate in a minimum of 3 structured reading sessions and how to log each session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- the infant must have a NICU LOS > 3 days;
- a dedicated caregiver, such as parent, relative, friend of the family, grandparent are present in NICU;
- the primary caregiver can read and speak in English.
Key exclusion criteria (4 listed)
- Infants with a confirmed diagnosis of hearing loss will be excluded from the study, as the intervention is based on auditory stimulation through shared reading;
- the caregiver has cognitive impairments or under legal guardianship;
- the caregiver is unable to speak;
- the infant is under foster care at the time of enrollment.
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 |
|---|---|---|
| Reading InterventionThe intervention consists of the following content: 1. Handouts explaining the benefits of reading to your infant will be provided and discussed at the time of enrollment. 2. Instructions outlining that a minimum of 3 reading sessions, lasting at least 2 minutes, should be provided to the infant, and how to log the reading sessions. 3. Information on how to obtain books from the NICU library if choosing to utilize that resource. Parents will be informed that they can bring in their own books from home should they want to. | Behavioural | Intervention Group |
Primary outcome
Change in Infant heart rate
Time frame: Baseline (at start of the intervention), 2 minutes into the intervention
Heart rate, will be abstracted from medical record review. Heart rate will be measured by the number of beats the infant's heart has per minute.
Change in Infant heart rate
Time frame: Baseline (at start of the intervention),15 minutes after the intervention
Heart rate, will be abstracted from medical record review. Heart rate will be measured by the number of beats the infant's heart has per minute.
Change in Infant Respiratory rate
Time frame: Baseline (at start of the intervention), 2 minutes into the intervention
Respiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Change in Infant Respiratory rate
Time frame: Baseline (at start of the intervention), 15 minutes after the intervention
Respiratory rate will be abstracted from medical record review. Respiratory rate will be measured by the number of breaths an infant takes per minute.
Change in Infant Oxygen saturation level
Time frame: Baseline (at start of the intervention), 2 minutes into the intervention
Oxygen saturations level will be abstracted from medical record review. Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
Change in Infant Oxygen saturation level
Time frame: Baseline (at start of the intervention), 15 minutes after the intervention
Oxygen saturations level will be abstracted from medical record review. Oxygen saturation will be measured via a pulse oximeter device, placed on the infants' hand or foot.
1 secondary outcome
Caregiver Outcome
Time frame: Survey will be supplied at 2-weeks, 4-weeks, and 6-months postpartum.
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 27 Aug 2026.
Related trials for Infant Admitted to Neonatal Intensive Care Unit (NICU)
Not yet recruitingObservational study
Neonatal Thrombocytopenia in the NICU
Thrombocytopenia, Neonatal Thrombocytopenia
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
Premature Birth, Respiration Failure
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Not yet recruiting
NeoSpHb Study: Can a Painless Device Detect Anaemia in Babies Without Blood Tests? A Study in the Neonatal Intensive Care Unit (NICU)
Anemia
Active, not recruiting
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Motor Delay, Premature Birth
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reading Intervention in people with Infant Admitted to Neonatal Intensive Care Unit (NICU), run by University of Texas Southwestern Medical Center.
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 3 inclusion and 4 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 27 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infant heart rate (time frame: Baseline (at start of the intervention), 2 minutes into the intervention). The study lists 6 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 27 Aug 2026.