“Be With My Baby”: Pilot Investigation of the Use of the Babybe System® to enhance Family-centered Developmental Care in the Neonatal Intensive care Unit

Principal Investigators: Terrie Inder, MBChB, MD, and Carmina Erdei, MD

Description of Study:

We understand that parents can’t always be in the NICU to do skin-to-skin care with their babies for many reasons. Through this study, we seek to evaluate:

 

1. If the BABYBE SYSTEM® is a feasible and effective way to supplement your baby’s care by simulating SSC when you are not able to hold your baby.

2. If the BABYBE SYSTEM® might potentially help your baby’s growth and development and improve your experience as a parent in the NICU.

 

We plan on enrolling 20 babies from our NICU at Brigham and Women’s Hospital over the course of 6 months to evaluate the two points listed above.

 

What Is My Baby’s Involvement In This Study? 

  1. Your baby will lay on the thin gel mattress, covered by a fitted sheet from the time you enrol in this study until they approach their due date.

  2. Around that time your baby will receive a brain MRI that will give us more information about their brain growth and development.

  3. Before your baby goes home with you, we will perform an examination to evaluate your baby’s development. We will also ask for your feedback regarding your parenting experience in the NICU and with the BABYBE SYSTEM®.

 

What is Skin-to-Skin Care (SSC) or Kangaroo Care? 

SSC and Kangaroo care is the practice of holding your baby to your chest directly on your skin. This allows your baby to feel an hear your movements, heartbeat, breath sounds and voice as you take the time to bond with them. SSC has been shown to reduce stress and improve the growth and development of babies, while also leading to better parent experience and parent-infant bonding. You can find more information and evidence for these therapies in the research articles listed below.

 

Resources and Scientific Articles about SSC and Kangaroo Care

  1. Charpak, N., Tessier, R., Ruiz, J. G., Hernandez, J. T., Uriza, F., Villegas, J., . . . Maldonado, D. (2017). Twenty-year follow-up of kangaroo mother care versus traditional care. Pediatrics, 139(1).

  2. Cattaneo A., Davanzo R., Worku B., Surjono A., Echeverria M., Bedri A., . . . Tamburlini G. (1998). Kangaroo mother care for low birthweight infants: A randomized controlled trial in different settings. Acta Pædiatrica, 87(9), 976-985.

  3. Feldman, R., & Eidelman, A. (2003). Skin-to-skin contact (Kangaroo Care) accelerates autonomic and neurobehavioural maturation in preterm infants. Developmental Medicine Child Neurology, 45(4), 274-281.

  4. Moore, E., Bergman, N., Anderson, G., & Medley, N. (2016). Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Of Systematic Reviews, 11.

  5. Cattaneo, Davanzo, Worku, Surjono, Echeverria, Bedri, . . . Tamburlini. (1998). Kangaroo mother care for low birthweight infants: A randomized controlled trial in different settings. Acta Pædiatrica, 87(9), 976-985.

  6. Feldman, R., Eidelman, A., Sirota, L., & Weller, A. (2002). Comparison of skin-to-skin (kangaroo) and traditional care: Parenting outcomes and preterm infant development. Pediatrics, 110(1), 16-26.

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FAQs for Families – Babybe

How long does my/the baby stay on the mattress?


They will stay on the mattress for several weeks until they reach around 36 weeks corrected (postmenstrual) gestational age. At that time, the hospital’s ‘Safe Sleep’ program begins to help prepare babies a safe transition home, at which time this intervention will conclude.




Is this considered safe sleep practice?


Preterm babies are not required to practice “Safe Sleep” until they reach an age closer to their due date- ideally by 35-36 weeks, or when they approach the time to transition to home. During your baby’s stay in the NICU, a “therapeutic positioning” approach will likely be used to maximize their comfort, growth and development. The BabyBe mattress is a supplemental therapeutic position intervention, the techno gel used is firm enough allow for safe use up to 36 weeks. Your baby’s team will consider ending this intervention before the target age of 36 weeks if your baby is ready to transition to home before this age.




What do I have to do to use the BabyBe?


  1. We will ask you to provide an updated voice recording every week for us to play for your baby when they are being changed and fed during their scheduled ‘cares’ sessions. To do this, we will provide you with a voice recorder and ask you to record yourself for about 15-20 minutes in a quiet place as you speak or read a book for your baby – or whatever else you consider soothing and would like them to hear.
  2. We will also ask you to calibrate the BabyBe System with your breathing rate and heart rate on a weekly basis. To do this, we will demonstrate how to hold the BabyBe ‘turtle’ on your chest while you sit and lean back in a relaxed position. Automatically, the turtle will sense your breathing rate and heart rate, and record these parameters to then relay them to your baby through the mattress.




Does the system play sounds at a level that is safe for my baby’s hearing?


Yes. The audio recordings of your voice and the heart beat sounds that are played through the gel mattress will only be just loud enough for your baby to hear. The volume is overall very low, such that it is generally only audible to adults when using a stethoscope on the mattress. It will not be any louder than the daily sounds they encounter as they are cared for, including regular speech or equipment noise.




What do I do if the baby seems to be bothered by the heartbeat or breathing movements?


If you believe your baby is bothered by the movements and sounds of the mattress, please let your nurse know and they will notify our research team to troubleshoot as needed. If all the equipment is functioning adequately, but the intervention seems to be upsetting for your baby, we will notify our senior research team, turn off the device, and disconnect the mattress.




How often do we play the audio recording of parents talking?


We will play these audio recordings several times a day as your baby is receving their “cares” sessions (when they are changed and fed).




Who do I contact if I am having a problem?


If any issues or questions arise, feel free to contact one of the members of the research team:

Kirsten Thiim

  • Research Asssistant

  • (617) 852-2652

  • kthiim@bwh.harvard.edu

Tina Steele

  • Senior Research Nurse

  • (617) 525-7376

  • tdufresne@bwh.harvard.edu

Liz Singh

  • Research Specialist

  • (617) 732-5209

  • esingh@bwh.harvard.edu





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