What is the mechanism of action of this treatment?

Common treatments for Postpartum Depression (PPD) include selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological interventions like cognitive-behavioral therapy (CBT) and emotional support. SSRIs work by increasing serotonin levels in the brain, which helps improve mood and emotional stability. Non-pharmacological treatments, such as the Mother's Recorded Voice intervention, provide psychological support and enhance mother-infant bonding. These treatments are essential for PPD patients as they address both the biological and emotional aspects of the disorder, promoting overall mental health and strengthening the mother-infant relationship.

What side effects are associated with this type of intervention?

Common treatments for postpartum depression (PPD) include psychotherapy and pharmacotherapy. Psychotherapy, such as cognitive-behavioral therapy (CBT) and interpersonal therapy (IPT), generally has minimal side effects, though some individuals may experience temporary emotional discomfort as they work through challenging issues. Pharmacotherapy, particularly selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), can have side effects such as nausea, fatigue, insomnia, dry mouth, and sexual dysfunction. It is important for patients to discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved brexanolone (Zulresso) for the treatment of postpartum depression, which is administered as a continuous intravenous infusion over 60 hours. Additionally, selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine are commonly prescribed off-label for postpartum depression. These treatments focus on alleviating depressive symptoms through pharmacological means. In contrast, the 'Mother's Recorded Voice' trial emphasizes emotional and psychological support by playing a mother's recorded voice to her preterm infant, aiming to improve maternal feelings and reduce stress, anxiety, and depression.

What other types of research exist?

Promising, novel alternatives for postpartum depression treatment in 2024 include: 1) Mindfulness-Based Cognitive Therapy (MBCT), which has shown broad symptom improvement and reduction in psychological distress. 2) Cognitive Behavioral Therapy (CBT), particularly telephone-based or group formats, which have been effective in managing depressive symptoms. 3) Music therapy, which has been beneficial in reducing anxiety and stress. 4) Acupuncture, which has shown efficacy in managing stress and anxiety. 5) Spiritual or religious interventions, which have been effective in reducing anxiety in specific patient populations.

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Mother's Recorded Voice for Premature Infants

N/A

Waitlist Available

Led By Narendra Dereddy, MD

Research Sponsored by AdventHealth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 23 days

Awards & highlights

Summary

This trial aims to help extremely preterm infants and their mothers by playing a recording of the mother's voice to the baby in the incubator. The goal is to reduce parental stress, anxiety, and depression while also stabilizing or improving the baby's vital signs. The mother's voice provides comfort to the baby and helps mothers feel more connected and less helpless.

Who is the study for?

This trial is for mothers over 18 with preterm infants born between 26 and nearly 31 weeks of gestation, without major congenital or chromosomal anomalies. The mothers must be willing to record their voice and complete questionnaires about their feelings and stress levels.

What is being tested?

The study tests the effect of playing a mother's recorded voice to her extremely preterm infant in the NICU when she can't be there. It aims to see if this can reduce maternal depression, anxiety, stress, and improve feelings towards the baby.

What are the potential side effects?

There are no direct medical side effects expected from this intervention as it involves only playing audio recordings. However, emotional responses may vary among participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 23 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 23 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Feelings questionnaire

Incidence of apneas, bradycardias and desaturation episodes

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Maternal voiceExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

NO intervention between week 2 and 3

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Postpartum Depression (PPD) include selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological interventions like cognitive-behavioral therapy (CBT) and emotional support. SSRIs work by increasing serotonin levels in the brain, which helps improve mood and emotional stability. Non-pharmacological treatments, such as the Mother's Recorded Voice intervention, provide psychological support and enhance mother-infant bonding. These treatments are essential for PPD patients as they address both the biological and emotional aspects of the disorder, promoting overall mental health and strengthening the mother-infant relationship.

Find a Location

Who is running the clinical trial?

DraegerUNKNOWN

1 Previous Clinical Trials

22 Total Patients Enrolled

AdventHealthLead Sponsor

112 Previous Clinical Trials

30,738 Total Patients Enrolled

Narendra Dereddy, MDPrincipal InvestigatorAdventHealth

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Maternal voice Clinical Trial Eligibility Overview. Trial Name: NCT04559620 — N/A

Postpartum Depression Research Study Groups: Maternal voice, Control

Postpartum Depression Clinical Trial 2023: Maternal voice Highlights & Side Effects. Trial Name: NCT04559620 — N/A

Maternal voice 2023 Treatment Timeline for Medical Study. Trial Name: NCT04559620 — N/A

~15 spots leftby Sep 2025

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