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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: June 30, 2020
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.
- 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.
Arms, Groups and Cohorts
- Experimental: Maternal Voice Exposure
- Infants enrolled will be exposed to maternal voice for 20 min immediately prior to being offered oral feedings. This exposure will be conducted 2 times a day until infant starts taking all enteral feeds orally.
Clinical Trial Outcome Measures
- Oral feeding volume
- Time Frame: Through study completion, average 40 weeks post menstrual age
- Effect of maternal voice immediately prior to feeding on oral feeding volumes in preterm infants
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 28 Weeks
Maximum Age: 40 Weeks
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Connecticut Children’s Medical Center
- Provider of Information About this Clinical Study
- Principal Investigator: Shabnam Lainwala, Principal Investigator, Attending Neonatologist – Connecticut Children’s Medical Center
- Overall Official(s)
- Shabnam Lainwala, MBBS, PhD, Principal Investigator, Connecticut Children’s Medical Center
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