Enteral Feeding
Conditions
Keywords
Maternal Voice
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.
Interventions
BEHAVIORALMaternal 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.
Sponsors
Connecticut Children's Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 40 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Oral Feedings | Oral feeding proportions were collected for baseline feed 3 hr prior to the intervention, for post intervention feed immediately after the intervention and for follow-up feed 3 hr after the intervention. | Effect of maternal voice immediately prior to feeding on oral feed proportions in preterm infants. Proportion of oral feeds is defined as the volume of oral intake divided by the prescribed volume for the feeding for each feeding session. The change from baseline to post intervention and follow- up is reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShabnam Lainwala, MBBS, PhD
Connecticut Children's Medical Center
Participant flow
Recruitment details
Subjects enrolled in Open bay NICU between 6/1/2020 and 9/30/2020.
Pre-assignment details
Only infants were considered enrolled in the study
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32 weeks STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
None listed