Clinical trial NCT05181020: Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants
Official title: Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Feeding
Keywords: Maternal Voice
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 28
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral feeding volume
timeFrame: Through study completion, average 40 weeks post menstrual age
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Shabnam Lainwala, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chhikara A, Hagadorn JI, Lainwala S. Effect of maternal voice on proportion of oral feeding in preterm infants. J Perinatol. 2023 Jan;43(1):68-73. doi: 10.1038/s41372-022-01493-4. Epub 2022 Aug 18.