Parental Infant BondingNCT02518997
Effects of Reading to Preterm Infants on Baby and Parents' Well Being
A study testing Parental Reading Aloud in people with Parental Infant Bonding and Cardio-respiratory Stability in Preterm NICU Infants, run by Georgetown University at 1 site in United States.
Trial summary
Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. Read more about this study
- Who is it for?
- Ages 7 days to 40 weeks
- Conditions the study is for
- Parental Infant Bonding, Cardio-respiratory Stability in Preterm NICU Infants
- What is being tested?
- Parental Reading Aloud
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 days to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks.
- Infants at least 7 days of life to allow for transition to extrauterine life.
- Parental Inclusion Criteria
- Agreement to the study with signed Informed Consent Form and HIPAA Authorization
- Visits on a regular basis (at least 3 times per week)
- Is literate (able to read)
Who cannot join
- Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team,
- infants with congenital hearing loss,
- chromosomal abnormalities,
- infants not expected to survive.
- Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. The investigators will follow rates of common preterm health issues while in the hospital and time to hospital discharge. Effects of bedside reading on parental stress and infant bonding will be measured and compared to usual rates of these indicators to determine if reading to babies reduces stress and enhances bonding.
Read the detailed description
The NICU at Georgetown University Hospital cares for approximately 100 infants per year in the study population between 26-34 weeks gestation. We have a patient population where parental daily visits are the norm, allowing for a study using live voices.
The investigators will approach parents of infants who meet entry criteria who are nearing one week of age after consultation with the clinical care team to determine stability. All preterm infants admitted to the NICU who are deemed stable enough to participate by the primary team will be approached for study participation.
After parental consent is obtained, the parents will be given an initial questionnaire to assess demographic data such as parental education and attitudes regarding reading to infants. Parents will be given a picture book with rhythmic sound patterns for reading aloud to their infant. Bedside nurses will help guide parents to the best time for infant reading. Time of parent reading (start and stop time) will be recorded in the infant's chart. Mothers and fathers will be allowed to read to the infant at separate reading times. A decibel monitor placed at the opening of the incubator will display the decibel level of parental voice.
Parents will be asked to read to their babies for at least 15 minutes but not more than 60 minutes per session. The total reading time for any 24 hour period can be up to 90 minutes.
Reading will occur with the infant in an incubator, in an open warmer or crib or while being held by parents. If the infant is in an incubator, parents will read with the portal closest to the parent open. For those babies who are in an open crib or warmer the parents will read close enough to the bedside so as not to be heard by neighboring patients. In older infants who are stable enough for kangaroo care or are out of bed being held by parents, reading can occur at those times, if desired by the parents. The Infant's location (in incubator, open bed, kangaroo care or parental holding) will be recorded in a study bedside binder.
Parents may also make a 30 minute recording on a digital recording device which can be played back to the baby twice per day if the parents are not expected to visit and the total reading time has not been met. Nursing staff will alternate between mother and father recorded sessions when neither parent is present and the total reading time for the day has not occurred.
Enrolling 80 infant/parent pairs will allow for subgroup analysis of Cardio Respiratory Events (CREs) in different corrected gestational ages (grouped into two cohorts 26-30 completed weeks and 31-34 completed weeks) and for comparison in effect of maternal and paternal voices. The study will not dictate who reads when both parents are present, but will encourage fathers to read if their visits are less frequent than mother's.
To assess changes in CREs, during NICU admission we will continuously record infant heart rate, respiratory rate, oxygen saturation, and CREs via software capable of downloading data directly from infant monitors used for routine clinical monitoring in the NICU, reducing variations in bedside charting and supplying a more complete documentation of the infant's cardiopulmonary status. Assessment of parental reading impact will be assessed at least three times per week and up to twice per day. Monitoring equipment is limited to recording three infants at one time so number of infants monitored per day will be impacted by total number of infants in the study at one time.
Changes in heart rate, respiratory rate, numbers of desaturation and apnea or bradycardia events will be scored for 3 reading session epochs; one hour before reading, during reading and one hour after parent reading will be measured. We will also compare CRE scores of reading times to CRE scores of similar periods throughout the day (eg 30 minutes before and after feedings). Enrolled infants who require high frequency ventilation will be temporarily withdrawn until the infant returns to conventional ventilation. If an infant is deemed too ill to participate by the primary team due to worsening in clinical status, he or she may be temporarily withdrawn until the primary team decides he/she is again stable enough to participate.
Parent-infant bonding will be assessed via a questionnaire administered four times during the study: before enrollment, at hospital discharge (average expected length of time 6 weeks) and 3-months after discharge. Attitudes toward reading to infants and patterns of reading at home after discharge will also be recorded and compared.
Frequency of parent-infant reading after discharge will be compared to historical controls via survey of families whose infants have been discharged from the NICU prior to the study initiation and exposure to subsequent study-initiated reading education efforts. This control group will be polled for parental education, feelings on reading to infants and frequency of that behavior at home in the first 3 months after hospital discharge to obtain a historical baseline for our study population. Parents of the prospective reading group will receive the same questionnaire at 3 months after discharge and these results will be compared.
Data on CREs will be recorded at multiple time points for the duration of care within an incubator and outcomes followed to hospital discharge, an average of 8 weeks. Parent-infant reading patterns will be followed up to 3 months after hospital discharge.
- Being tested
- Parental Reading Aloud
- Keywords
- Preterm Infants, Bedside Reading aloud, Parental wellbeing, Parental Bonding, cardio-respiratory stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Reading AloudOther
Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring.
| Study group | Role | What they receive |
|---|---|---|
| All enrolled infants | Experimental | All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. Receives: Other: Parental Reading Aloud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Oxygen Saturation Measurements <85%
Percent of measured oxygen saturations recorded as less than 85%
Measured: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parental Infant BondingStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Scala, Georgetown University
- Investigators
- Melissa L Scala, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518997
- Sponsor's protocol ID
- 2014-1464
- Status last verified
- Jan 2020
- First submitted
- 10 Mar 2015
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reading to Preterm Infants on Baby and Parents' Well Being
- ClinicalTrials.gov ID
- NCT02518997
- Acronym / sponsor ID
- 2014-1464
- Keywords
- Preterm Infants, Bedside Reading aloud, Parental wellbeing, Parental Bonding, cardio-respiratory stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Posted 28 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. The investigators will follow rates of common preterm health issues while in the hospital and time to hospital discharge. Effects of bedside reading on parental stress and infant bonding will be measured and compared to usual rates of these indicators to determine if reading to babies reduces stress and enhances bonding.
Detailed description
The NICU at Georgetown University Hospital cares for approximately 100 infants per year in the study population between 26-34 weeks gestation. We have a patient population where parental daily visits are the norm, allowing for a study using live voices.
The investigators will approach parents of infants who meet entry criteria who are nearing one week of age after consultation with the clinical care team to determine stability. All preterm infants admitted to the NICU who are deemed stable enough to participate by the primary team will be approached for study participation.
After parental consent is obtained, the parents will be given an initial questionnaire to assess demographic data such as parental education and attitudes regarding reading to infants. Parents will be given a picture book with rhythmic sound patterns for reading aloud to their infant. Bedside nurses will help guide parents to the best time for infant reading. Time of parent reading (start and stop time) will be recorded in the infant's chart. Mothers and fathers will be allowed to read to the infant at separate reading times. A decibel monitor placed at the opening of the incubator will display the decibel level of parental voice.
Parents will be asked to read to their babies for at least 15 minutes but not more than 60 minutes per session. The total reading time for any 24 hour period can be up to 90 minutes.
Reading will occur with the infant in an incubator, in an open warmer or crib or while being held by parents. If the infant is in an incubator, parents will read with the portal closest to the parent open. For those babies who are in an open crib or warmer the parents will read close enough to the bedside so as not to be heard by neighboring patients. In older infants who are stable enough for kangaroo care or are out of bed being held by parents, reading can occur at those times, if desired by the parents. The Infant's location (in incubator, open bed, kangaroo care or parental holding) will be recorded in a study bedside binder.
Parents may also make a 30 minute recording on a digital recording device which can be played back to the baby twice per day if the parents are not expected to visit and the total reading time has not been met. Nursing staff will alternate between mother and father recorded sessions when neither parent is present and the total reading time for the day has not occurred.
Enrolling 80 infant/parent pairs will allow for subgroup analysis of Cardio Respiratory Events (CREs) in different corrected gestational ages (grouped into two cohorts 26-30 completed weeks and 31-34 completed weeks) and for comparison in effect of maternal and paternal voices. The study will not dictate who reads when both parents are present, but will encourage fathers to read if their visits are less frequent than mother's.
To assess changes in CREs, during NICU admission we will continuously record infant heart rate, respiratory rate, oxygen saturation, and CREs via software capable of downloading data directly from infant monitors used for routine clinical monitoring in the NICU, reducing variations in bedside charting and supplying a more complete documentation of the infant's cardiopulmonary status. Assessment of parental reading impact will be assessed at least three times per week and up to twice per day. Monitoring equipment is limited to recording three infants at one time so number of infants monitored per day will be impacted by total number of infants in the study at one time.
Changes in heart rate, respiratory rate, numbers of desaturation and apnea or bradycardia events will be scored for 3 reading session epochs; one hour before reading, during reading and one hour after parent reading will be measured. We will also compare CRE scores of reading times to CRE scores of similar periods throughout the day (eg 30 minutes before and after feedings). Enrolled infants who require high frequency ventilation will be temporarily withdrawn until the infant returns to conventional ventilation. If an infant is deemed too ill to participate by the primary team due to worsening in clinical status, he or she may be temporarily withdrawn until the primary team decides he/she is again stable enough to participate.
Parent-infant bonding will be assessed via a questionnaire administered four times during the study: before enrollment, at hospital discharge (average expected length of time 6 weeks) and 3-months after discharge. Attitudes toward reading to infants and patterns of reading at home after discharge will also be recorded and compared.
Frequency of parent-infant reading after discharge will be compared to historical controls via survey of families whose infants have been discharged from the NICU prior to the study initiation and exposure to subsequent study-initiated reading education efforts. This control group will be polled for parental education, feelings on reading to infants and frequency of that behavior at home in the first 3 months after hospital discharge to obtain a historical baseline for our study population. Parents of the prospective reading group will receive the same questionnaire at 3 months after discharge and these results will be compared.
Data on CREs will be recorded at multiple time points for the duration of care within an incubator and outcomes followed to hospital discharge, an average of 8 weeks. Parent-infant reading patterns will be followed up to 3 months after hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled infants | Experimental | Other: Parental Reading AloudAll participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. |
Who may qualify
- Ages
- 7 days to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks.
- Infants at least 7 days of life to allow for transition to extrauterine life.
- Parental Inclusion Criteria
- Agreement to the study with signed Informed Consent Form and HIPAA Authorization
- Visits on a regular basis (at least 3 times per week)
Key exclusion criteria (6 listed)
- Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team,
- infants with congenital hearing loss,
- chromosomal abnormalities,
- infants not expected to survive.
- Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)
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 |
|---|---|---|
| Parental Reading AloudInfants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring. | Other | All enrolled infants |
Primary outcome
Percent of Oxygen Saturation Measurements <85%
Time frame: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks
Percent of measured oxygen saturations recorded as less than 85%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Melissa L Scala, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Reading Aloud in people with Parental Infant Bonding and Cardio-respiratory Stability in Preterm NICU Infants, run by Georgetown University at 1 site in United States.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Oxygen Saturation Measurements <85% (time frame: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks). 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 28 Jan 2020.