Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants

Enteral Feeding Clinical Trial

Official title:

Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181020
• Other study ID #: ConnecticutCMC
• Status: Completed
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: February 2023
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oral feeding is one of the primary functions of the neonatal brain. In preterm infant population, competency at oral feeding is one of the major milestones in preparation for discharge. Mother's voices have been shown to have a net stimulatory effect and premature infants have been found to have increased cardiorespiratory stability after listening to mother's voices. Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.

Description:

Achievement of full oral feedings is directly associated with length of neonatal intensive care unit stay. Extremely low gestational age infants with dysfunctional oral feeding in early childhood have lower cognitive and language skills compared with those with normal oral feedings. Also, previous studies have shown a strong association between oral feeding and infant maturity and behavior state and positive feeding experience. In recent years, there is emerging evidence that non-medical developmental care interventions in the neonatal intensive care units such as kangaroo care, single family rooms, and music and massage therapy may be beneficial for preterm infants and improve their long term neurodevelopmental outcomes. Beneficial effects of exposure to mother's voice and sounds on preterm infants in the neonatal intensive care units are well documented. Our study proposes to examine the association between exposure to mother's voice prior to and during oral feeding and oral feeding volume and rate in preterm infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 40 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants born between gestational age of 28 0/7 weeks and 34 6/7 weeks

• Ready to start oral feeding attempts

• Taking a total daily oral intake < 50% of feeds on average in 2 days prior to starting intervention

• Mothers who are English speaking and over 18 years old

Exclusion Criteria:

• Major congenital anomalies

• Non-English speaking

• Family history of suspected congenital hearing loss

• Failed hearing test in NICU

• Grade three to four intraventricular hemorrhage or periventricular leukomalacia

• necrotizing enterocolitis requiring treatment

• Congenital infections such as cytomegalovirus which can lead to sensorineural hearing loss

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Behavioral:
• Maternal Voice Exposure
Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral feeding volume	Effect of maternal voice immediately prior to feeding on oral feeding volumes in preterm infants	Through study completion, average 40 weeks post menstrual age