Mother's Recorded Voice for Preterm Infants
Mother's Recorded Voice for Preterm Infants
The early birth of a premature baby can be a devastating and unplanned situation for parents.
 Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel
 helpless; bonding may be more difficult, parental control is superseded by medical necessity
 and parents can feel tremendous guilt whenever they are unable to be present at their baby's
 bedside. The investigators believe that giving parents an opportunity to provide comfort in
 the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling
 about her baby in the NICU. The investigators hypothesize that playing the mother's recorded
 voice to her extremely preterm infant while in the incubator when she cannot be present will
 improve the depression, anxiety and stress as well as overall feeling about her baby. The
 investigators will assess the change in depression, anxiety and stress with the use of a
 validated tool (the DASS21), as a result of the intervention. The investigators will also
 assess the improvement of her feelings with a questionnaire () to be administered before and
 after the intervention. The investigators predict that her depression, anxiety and stress as
 well as positive feeling will increase after the intervention. The investigators also predict
 that the infant's vital signs will remain stable and/or improve when the recording is played.
Background Information and Scientific Rationale The AdventHealth Orlando NICU is the first
 U.S. hospital to utilize the Babyleo in a clinical setting. Personnel were trained by Dräger
 representatives and the units have been in use for over 2 years. During that time, personnel
 have not used the Audio Port, located on the back of the bed. The Audio Port allows sound to
 be played inside the incubator at no more than 55 dB, which is within the guidelines set
 forth by the American Academy of Pediatrics for the target population of this project.

 The early birth of a premature baby can be a devastating and unplanned situation for parents.
 Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel
 helpless; bonding may be more difficult, parental control is superseded by medical necessity
 and parents can feel tremendous guilt whenever they are unable to be present at their baby's
 bedside.

 The investigators will attempt to provide some comfort and control to the parents of
 premature infants by implementing this project. Research has shown that when used
 appropriately in the premature to term infant population, specific sounds can result in "a
 shorter hospital stay, improved feeding skills, improved behavior state and improved
 physiological status".

 The investigators believe that giving parents an opportunity to provide comfort in the form
 of the mother's voice, pre-recorded and played to her baby, will improve her feeling about
 her baby in the NICU. As the process of recording the mother's voice will be aided by trained
 Music Therapists, parents will also gain knowledge about developmentally appropriate methods
 of interacting with their infant.

 Consideration also needs to be given to staff education. It has long been ingrained in staff
 that "noise" for the premature infant is undesirable and upsetting to their immature nervous
 system. While this can be true, studies have shown that appropriate sounds, introduced at the
 right time, can aid in brain development and the later acquisition of language. Babies do not
 necessarily need to live in a sound-free environment; in the womb, they are continually
 exposed to sound. However, staff are very protective of keeping premature infants from
 becoming stressed, and so the mention of introducing sound into their quiet incubator causes
 a great deal of consternation. Detailed explanation and staff buy-in will be very important
 for this study.

 Multiple studies have shown that providing a recorded maternal voice in the form of
 conversation, singing, or book reading to her preterm infant can have significant beneficial
 effects. It has been shown that maternal voice exposure results in improved infants'
 cardio-respiratory functions, (1-3), relieving pain during noxious procedures (4), improved
 circadian rhythms (5), reduced incidence of apnea and bradycardia (6) and overall improvement
 of developmental outcomes (7-9). The mother providing her voice to her fetus during the third
 trimester of pregnancy also has beneficial effects on her own anxiety and depression (10,11).
 Several studies have shown the safety and feasibility of introducing sound into an incubator
 (14,15,16). However, other studies have introduced music into the incubator via speakers,
 headphones or an audio player with loudspeakers (21).

 The investigators propose to use the Babyleo's built-in audio port. The mother will record an
 audio CD with the guidance of Music Therapy. This will be played on a CD player for no more
 than 30 minutes at a time, 4 times a day. The recorder is plugged in to the audio port by a
 standard cable from the headset port of the CD player.

 Study Objectives

 Primary Objective/Aim/Goal/Hypothesis Preterm birth is associated with a higher rate of
 postpartum depression disorders (17,18,19,20). This is in part due to feeling of "let down"
 because the mothers are unable to care for her baby and has to leave the baby in the NICU for
 care. The "let down" feeling may be lessened if mothers are given the opportunity to express
 their concern by producing a recording for their babies. The investigators hypothesize that
 playing the mother's recorded voice to her extremely preterm infant while in the incubator
 when she cannot be present will improve the depression, anxiety and stress as well as overall
 feeling about her baby. The study team will assess the change in depression, anxiety and
 stress with the use of a validated tool (the DASS21), as a result of the intervention. The
 investigators will also assess the improvement of her feelings with a questionnaire () to be
 administered before and after the intervention. The investigators predict that her
 depression, anxiety and stress as well as positive feeling will increase after the
 intervention.

 Secondary Objective/Aim/Goal/Hypothesis

 1. The infant's vital signs will remain stable and/or improve when the recording is played.
 Vital signs for the purpose of this study will be defined as; heart rate and respiratory
 rate. Blood pressure and temperature will be recorded if available. Vital signs will be
 assessed both before the recording and during the recording. Over time, the study team
 predicts vital signs will remain within acceptable parameters.

 2. Playing mother's voice will reduce the incidence of apnea, bradycardia and desaturation
 of the study infants.

 Study Design Research Design This is a randomized, prospective clinical study.

 Research Intervention Description As shown in the diagram below, maternal consent will be
 obtained during the first week of life and the baby will be randomized as shown in the
 diagram below. Group 1 mothers' voice will be played between week 2 and 3 while group 2
 mothers' voice will be played after week 3 but no research data will be collected. Group 2
 will therefore serve as control.

 Between consent and the infant reaching two weeks of life, the mother will be given time to
 acclimate to having a child in the NICU, and to adjust to the fact that she has delivered
 early and not at term. After seven days and prior to meeting with the music therapist, she
 will be asked to complete the DASS21 and the questionnaire that expresses her feelings about
 her baby in the NICU. Surveys will be completed in Survey Monkey on a research department
 tablet or via the mother's own electronic device. She will then work closely with Music
 Therapy staff, receiving education about appropriate developmental sound for her baby and to
 record her voice on a CD.

 For those who have been randomized to receive the intervention, the mother's recorded voice
 will be played via the incubator's audio port. At week three (+2 days), the DASS21 and
 feeling questionnaire will be repeated for both groups. Both groups will then be allowed to
 play the recording within guidelines, but no further research data will be collected. Staff
 education will be conducted by research personnel and selected staff members (Ambassadors).
 Ambassadors will also facilitate playing of the recording, particularly on night shift, to
 assist with parent education and to support staff efforts.

 Research staff will approach the parents of babies born at 260/7 to 306/7 weeks gestation and
 explain the project, asking for permission to participate and obtaining consent. A Parent
 Education Sheet, prepared by the Developmental Committee, will be given to each participating
 family.

 Demographic and clinical data, including mother's age, race, level of education, and infant's
 gestation, gender, birth weight, Apgar score, ventilatory support, and IVH, will be collected
 from the medical records.

 Under the guidance of the Music Therapy Department, the mother will create a sound recording,
 which could include any and all of the following: the mother's heartbeat, the mother speaking
 to her child (i.e., reading a book, expressing her love and hopes for the future), the mother
 singing to her child, etc. Mother can choose the subject matter. She can also choose from a
 list of available books/songs. The recordings will be played for the infant for 1 week as
 intervention, when visitors are not present. The recording will be 30 minutes long, and will
 be played four times a day, at a time the clinical team determines is appropriate for that
 baby. There will be a 30-minute period of silence after the recording. A cord is inserted
 into the headphone port of the CD player and then into the Babyleo Audio Port, which is the
 same type of port as the headphone port (male/male connector). The set-up will be done by a
 member of the research team, the bedside RN simply has to push play. Data will be collected
 regarding the infant's tolerance for the recording. Vital signs will be recorded during the
 study intervention 30 minutes before the recording is played and then once during the
 intervention. The incidence of daily ABDs (apnea, bradycardia, desaturations) are routinely
 documented in the EMR and will be obtained from the medical record: A. Apnea for > 20
 seconds, B. Heart rate < 80 beats per minute C. Oxygen saturations <80 The study team expect
 that the incidence of ABDs will decrease by the end of the intervention, although changes in
 ABDs may be multifactorial and influenced by increased maturity, level of illness or
 respiratory status.The infant's nurse may, at his/her discretion, discontinue playing the
 recording for any reason. While multiple studies have shown the safety of introducing voice
 to the premature baby, if the infant has 3 ABDs during 3 consecutive interventions, the
 infant will be taken off the study. When the infant comes out of the incubator and into a
 crib, the study team can give the parent the recording via CD or audio file (mp3 or mp4).

 Study Site(s)/Location(s) and Number of Subjects This study will take place at the
 AdventHealth Orlando NICU. Sample size will be calculated using the DASS21 (our primary
 outcome) of the first ten mothers enrolled in the study. The investigators will aim for a 30%
 relative increase in Feeling score with 80% power Plan.
Criteria:

 Inclusion Criteria:

 Mother

 -  Commitment to finish all questionnaires and to participate in the creation of a CD to
 be played to her baby.

 -  Older than 18 years of age

 Infant

 • Gestational age between 26 0/7 and 30 6/7 weeks

 Exclusion Criteria:

 Mother

 • Younger than 18 years

 Infant

 • Major congenital or chromosomal anomalies