Preterm Birth Clinical Trial
Official title:
Evaluating the Effect of Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance in Infants With Feeding Dysfunction
This is a research study to determine if an experimental device called the NTrainer can improve oral feeding skills more quickly and more effectively than traditional methods in infants who are at high risk of feeding dysfunction and delayed hospital discharge.
One day prior to starting the study treatment, sucking strength and coordination will be
measured on all enrolled infants using the NTrainer device in its "NeoSuck RT" assessment
mode (See Appendix A). They will also be clinically assessed by an Infant Feeding Specialist
using clinical assessment tools including the NOMAS and EFS (see Appendix B). After the
assessment a feeding plan will be developed for use by the infant's bedside nurses. This
feeding plan will include but not be limited to the use of techniques such as oromotor
stimulation, side-lying, pacing, and slow flow nipples. After the clinical and NeoSuck
assessments, infants will be randomized to receive either "Clinical" or "NTrainer"
intervention. The intervention period will be 10 days.
For study intervention feedings, the infant will undergo a brief exam of physiologic state,
using the Oral Feeding Readiness Assessment portion of the EFS. If the infant is determined
to be ready to feed (s)he infant will be cradled in a supportive inclined posture, swaddled,
with limbs positioned at midline, and background/overhead lighting dimmed in the area. The
infant will remain connected to the usual ICN monitors at all times for observation of
respiration, heartbeat and oxygen saturation.
In the Clinical group bottle feedings will be attempted by the bedside nurses, using
techniques suggested in the feeding plan. The Infant Feeding Specialist will observe at
least one feeding per day to assure that the feeding plan is being adhered to. If, in the
judgment of the person feeding the infant, the infant is unable to complete the bottle
feeding, the remaining volume will be given via an indwelling gavage tube. During all gavage
feedings, both total and partial, infants will be offered a pacifier to suck on.
In the NTrainer group, three feedings per day will be given via gavage tube while the infant
is receiving NTrainer stimulation. The stimulation will be done by alternating 3 minute
epochs of NTrainer stimulation with 3 minutes of sucking on a regular pacifier, up to a
total time of 30 minutes. Bottle feedings will be attempted at the other daily feedings by
the bedside nurse using techniques suggested by the feeding plan. If the infant is unable to
complete the bottle feeding, the remaining volume will be given via an indwelling gavage
tube. During all gavage feedings, both total and partial, infants will be offered a pacifier
to suck on.
Every other day, 15 minutes prior to a feeding that is not one of the study sessions, each
infant's suck strength and coordination will be measured using the NTrainer device in its
"NeoSuck RT" Assessment mode.
If the infant is able to successfully bottle feed the full prescribed volume for 5 of 8
feedings per 24 hours, the study intervention will end.
On the day after the study intervention period is completed each infant will be assessed by
an investigator unaware of the infant's study group assignment. The assessment will include
(1) a 3-minute measurement of sucking strength and coordination using "NeoSuck RT", and (2)
two observational checklists (NOMAS and EFS) used to score infant feeding behaviors. The
amount of oral feeding as a percentage of daily feeding volume will be recorded, as well as
the number of feeding-associated apnea/bradycardia/oxygen desaturation events in the
preceding 24 hours.
The NTrainer recordings will be interpreted by researchers at the University of Kansas, but
each baby's medical information will be kept confidential. The NTrainer study results will
not become part WakeMed records. Each baby's study records will be available through the
Neonatology division of WakeMed Faculty Physicians.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
| Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
| Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
| Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
| Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
| Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
| Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
| Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
| Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
| Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
| Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
| Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
| Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
| Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
| Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
| Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
| Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
| Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
| Completed |
NCT04021654 -
What is the Future of Vulnerable New-borns
|