Mother's Recorded Voice for Preterm Infants

NCT04559620 | Completed

• 1 other identifier: 1575033
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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 Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside.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.

Conditions

Maternal Depressive Disorder Complicating Childbirth; Preterm Birth; Maternal Anxiety Disorder Complicating Childbirth

Outcome Measures

Primary Outcomes (1)

• Maternal response to Depression, Anxiety, and Stress Scale(DASS)

  (DASS is a 1-21 questionnaire where a higher score=worse outcome)

  Baseline to 23 days

Secondary Outcomes (2)

• Incidence of apneas, bradycardias and desaturation episodes

  Up to 23 days

• Feelings questionnaire

  Up to 23 days

Study Arms (2)

Maternal voice

EXPERIMENTAL

Mother's voice will be played for 1 week between week 2 and 3 of life

Other: Maternal voice

Control

NO INTERVENTION

NO intervention between week 2 and 3

Interventions

Maternal voice OTHER

Maternal voice (song/ words) played in the incubator for 30mins x4/day x 7 days

Maternal voice

Eligibility Criteria

• Age: Up to 3 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Mother
• Younger than 18 years
• Infant
• Major congenital or chromosomal anomalies

Sponsors & Collaborators

• AdventHealth: lead
• Draeger: collaborator

Study Sites (1)

AdventHealth

Orlando, Florida, 32803, United States

Location

Related Publications (4)

• Weigl T, Schneider N, Stein A, Felderhoff-Muser U, Schedlowski M, Engler H. Postpartal Affective and Endocrine Differences Between Parents of Preterm and Full-Term Infants. Front Psychiatry. 2020 Apr 1;11:251. doi: 10.3389/fpsyt.2020.00251. eCollection 2020.

  PMID: 32296356 BACKGROUND

• Wirth L, Dorn F, Wege M, Zemlin M, Lemmer B, Gorbey S, Timmesfeld N, Maier RF. Effects of standardized acoustic stimulation in premature infants: a randomized controlled trial. J Perinatol. 2016 Jun;36(6):486-92. doi: 10.1038/jp.2016.1. Epub 2016 Feb 18.

  PMID: 26890554 RESULT

• van der Heijden MJ, Oliai Araghi S, Jeekel J, Reiss IK, Hunink MG, van Dijk M. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials. PLoS One. 2016 Sep 8;11(9):e0161848. doi: 10.1371/journal.pone.0161848. eCollection 2016.

  PMID: 27606900 RESULT

• Dereddy N, Moats RA, Ruth D, Pokelsek A, Pepe J, Wadhawan R, Oh W. Maternal recorded voice played to preterm infants in incubators reduces her own depression, anxiety and stress: a pilot randomized control trial. J Matern Fetal Neonatal Med. 2024 Dec;37(1):2362933. doi: 10.1080/14767058.2024.2362933. Epub 2024 Jun 23.

  PMID: 38910112 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Narendra Dereddy, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 23, 2020
• Study Start: March 25, 2021
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)