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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All enrolled infants | Experimental | All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parental Reading Aloud | Other | Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Oxygen Saturation Measurements <85% | Percent of measured oxygen saturations recorded as less than 85% | While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks |
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Inclusion Criteria:
Parental Inclusion Criteria
Exclusion Criteria:
Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)
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| Name | Affiliation | Role |
|---|---|---|
| Melissa L Scala, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Infants | All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Infants | All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Oxygen Saturation Measurements <85% | Percent of measured oxygen saturations recorded as less than 85% | All enrolled infants had measured oxygen saturations at 4 time periods: during reading exposure and 3 hours before reading, 1 hour before reading and 1 hour after reading | Posted | Mean | Full Range | Percent Oxygen saturation measurements | While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks | Oxygen saturation measurements | Oxygen saturation measurements |
|
For the extent of the infant's hospitalization, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Infants | All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring. |
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The number of reading events at the lowest gestational ages was limited and an equal number of reading events were unavailable for all infants at all gestational ages.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Scala | Stanford University | 650-723-5711 | mscala@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2019 | Oct 24, 2019 | Prot_SAP_000.pdf |
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| Participants |
|
| Age, Continuous | Mean | Full Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| gestational age at birth | Mean | Full Range | weeks |
|
| postmenstrual age at study entry | Mean | Full Range | weeks |
|
| Birth weight | Mean | Full Range | grams |
|
Infants with oxygen saturations measured 3 hours before reading exposure
All enrolled infants
| OG002 | Infants 1 Hour Before Reading Exposure | All enrolled infants. Infants with oxygen saturations measured 1 hour before reading exposure |
| OG003 | Infants 1 Hour After Reading Exposure | Infants with oxygen saturation data measured 1 hour after reading exposure All enrolled infants |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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