CTICU Pacifier Activated Music Player and Mother's Voice

NCT03035552 | Completed DMC

• 1 other identifier: IRB16-00493
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS) using contingent positive reinforcement with mother's voice can improve the feeding outcomes of infants with congenital heart defect (CHD) at high risk for oral motor problems.

Conditions

Heart Defects, Congenital

Keywords

Congenital heart disease (CCHD); Non-Nutritive Suck

Outcome Measures

Primary Outcomes (1)

• Oral feeding Efficiency

  Continuous measure of suck strength and suck rate during oral feeding via PAM sensor, as well as suck burst pattern and average oral feeding volumes.

  Depending on randomization, 5 days pre-operation (group 1) or 5 days post-operation (group 2)

Secondary Outcomes (2)

• Oral feeding development

  Thirty days post-operation

• Neurodevelopment

  Twelve months

Study Arms (2)

Treatment prior to surgery

EXPERIMENTAL

Infants randomized to receive the pacifier activated music player and mother's voice treatment prior to surgery for 5 sessions, and mother's voice playing freely post surgery.

Behavioral: Pacifier activated music player

Treatment post surgery

EXPERIMENTAL

Infants randomized to receive the mother's voice playing freely prior to surgery,and pacifier activated music player and mother's voice treatment post surgery for 5 sessions.

Behavioral: Pacifier activated music player

Interventions

Pacifier activated music player BEHAVIORAL

Therefore the immediate goal of the current proposal is to demonstrate that intensive NNS-training using reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD using a randomized controlled trial (RCT) design, with wait-list controls to ensure that infants in the trial all benefit from a treatment with only demonstrated positive effects. Establishment of optimal NNS patterns in the first 6 months after birth in these infants will improve downstream feeding skills and may promote better motor and language outcomes by one year of age.

Also known as: PAM

Treatment post surgery; Treatment prior to surgery

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants that have a diagnosis of a complex congenital heart defect and scheduled for a surgical intervention; meet CTICU feeding guidelines criteria. Infants with acquired brain injury will be included, as well as those whose mothers speak languages other than English.

You may not qualify if:

• Infants that are on assisted ventilation, continuous positive airway pressure, general anesthesia within 24 hours; lethal congenital abnormalities or congenital brain malformation.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (15)

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

  PMID: 24446411 BACKGROUND

• Brosig C, Mussatto K, Hoffman G, Hoffmann RG, Dasgupta M, Tweddell J, Ghanayem N. Neurodevelopmental outcomes for children with hypoplastic left heart syndrome at the age of 5 years. Pediatr Cardiol. 2013 Oct;34(7):1597-604. doi: 10.1007/s00246-013-0679-3. Epub 2013 Mar 16.

  PMID: 23503929 BACKGROUND

• Walker K, Badawi N, Halliday R, Stewart J, Sholler GF, Winlaw DS, Sherwood M, Holland AJ. Early developmental outcomes following major noncardiac and cardiac surgery in term infants: a population-based study. J Pediatr. 2012 Oct;161(4):748-752.e1. doi: 10.1016/j.jpeds.2012.03.044. Epub 2012 May 10.

  PMID: 22578999 BACKGROUND

• Luyckx K, Missotten L, Goossens E, Moons P; i-DETACH Investigators. Individual and contextual determinants of quality of life in adolescents with congenital heart disease. J Adolesc Health. 2012 Aug;51(2):122-8. doi: 10.1016/j.jadohealth.2011.11.007. Epub 2012 Feb 22.

  PMID: 22824441 BACKGROUND

• Cassidy AR, White MT, DeMaso DR, Newburger JW, Bellinger DC. Executive Function in Children and Adolescents with Critical Cyanotic Congenital Heart Disease. J Int Neuropsychol Soc. 2015 Jan;21(1):34-49. doi: 10.1017/S1355617714001027. Epub 2014 Dec 9.

  PMID: 25487044 BACKGROUND

• Jackson JL, Misiti B, Bridge JA, Daniels CJ, Vannatta K. Emotional functioning of adolescents and adults with congenital heart disease: a meta-analysis. Congenit Heart Dis. 2015 Jan-Feb;10(1):2-12. doi: 10.1111/chd.12178. Epub 2014 Feb 26.

  PMID: 24612910 BACKGROUND

• Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.

  PMID: 23582139 BACKGROUND

• Averin K, Uzark K, Beekman RH 3rd, Willging JP, Pratt J, Manning PB. Postoperative assessment of laryngopharyngeal dysfunction in neonates after Norwood operation. Ann Thorac Surg. 2012 Oct;94(4):1257-61. doi: 10.1016/j.athoracsur.2012.01.009. Epub 2012 Mar 14.

  PMID: 22421593 BACKGROUND

• Dewan K, Cephus C, Owczarzak V, Ocampo E. Incidence and implication of vocal fold paresis following neonatal cardiac surgery. Laryngoscope. 2012 Dec;122(12):2781-5. doi: 10.1002/lary.23575. Epub 2012 Sep 5.

  PMID: 22952115 BACKGROUND

• Sachdeva R, Hussain E, Moss MM, Schmitz ML, Ray RM, Imamura M, Jaquiss RD. Vocal cord dysfunction and feeding difficulties after pediatric cardiovascular surgery. J Pediatr. 2007 Sep;151(3):312-5, 315.e1-2. doi: 10.1016/j.jpeds.2007.03.014. Epub 2007 Jun 26.

  PMID: 17719946 BACKGROUND

• Davies RR, Carver SW, Schmidt R, Keskeny H, Hoch J, Pizarro C. Laryngopharyngeal dysfunction independent of vocal fold palsy in infants after aortic arch interventions. J Thorac Cardiovasc Surg. 2014 Aug;148(2):617-24.e2. doi: 10.1016/j.jtcvs.2013.05.054. Epub 2013 Nov 26.

  PMID: 24290573 BACKGROUND

• Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.

  PMID: 11060529 BACKGROUND

• Pereira Kda R, Firpo C, Gasparin M, Teixeira AR, Dornelles S, Bacaltchuk T, Levy DS. Evaluation of swallowing in infants with congenital heart defect. Int Arch Otorhinolaryngol. 2015 Jan;19(1):55-60. doi: 10.1055/s-0034-1384687. Epub 2014 Nov 5.

  PMID: 25992152 BACKGROUND

• Skinner ML, Halstead LA, Rubinstein CS, Atz AM, Andrews D, Bradley SM. Laryngopharyngeal dysfunction after the Norwood procedure. J Thorac Cardiovasc Surg. 2005 Nov;130(5):1293-301. doi: 10.1016/j.jtcvs.2005.07.013. Epub 2005 Oct 13.

  PMID: 16256781 BACKGROUND

• Kjeldsen CP, Emery L, Simsic J, He Z, Stark AR, Neel ML, Maitre NL. Contingent Mother's Voice Intervention Targeting Feeding in Hospitalized Infants with Critical Congenital Heart Defects. Children (Basel). 2023 Sep 30;10(10):1642. doi: 10.3390/children10101642.

  PMID: 37892305 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nathalie Maitre, MD. PhD

  Perinatal Research Institute, Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessors and the investigator are masked to the group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomized to Pacifier Activated Lullaby (mother's voice contingent on suck, 15 minutes, 5 sessions) before surgery or and Sounds of Love (mother's voice playing freely, 15 minutes, 5 sessions). Arm 2: Sounds of love before surgery, Pacifier activated lullaby after the surgery.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 30, 2017
• Study Start: September 15, 2016
• Primary Completion: January 31, 2019
• Study Completion: December 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)