Treatment for Bottle Feeding

Beth Israel Deaconess Medical Center, Boston, MA
Bottle Feeding+2 More Conditions
Eligibility
< 18
All Sexes

Study Summary

This trial will compare the two most common bottle-feeding positions for preterm infants - side-lying and supine - to see which is more effective.

Eligible Conditions
  • Bottle Feeding
  • Infant Development
  • Premature Infant Diseases

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

7 Primary · 4 Secondary · Reporting Duration: 5-30 minutes post-baseline

5-30 minutes post-baseline
Infant behavioral responses to the feeding position - Infant feeding skill
Infant behavioral responses to the feeding position - Suck-breathe coordination
Day 150
Infant characteristics associated with the intervention response - Overall severity of illness
Infant characteristics associated with the intervention response - Severity of lung disease
At enrollment
Infant characteristics associated with the intervention response - Infant's sex
At the end of the feeding observation, up to 30 minutes post-feeding
Infant characteristics associated with the intervention response - Maturity level
Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Heart rate (HR)
Infant physiologic responses to the feeding position - Heart rate variability (HRV)
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
Infant physiologic responses to the feeding position - Respiratory rate (RR)
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

0 Treatment Group

60 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5-30 minutes post-baseline

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,399 Previous Clinical Trials
3,748,891 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
791 Previous Clinical Trials
849,500 Total Patients Enrolled
Boston CollegeLead Sponsor
34 Previous Clinical Trials
23,108 Total Patients Enrolled
Jinhee Park, PhD, RNPrincipal InvestigatorBoston College

Eligibility Criteria

Age < 18 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Babies born before 35 weeks of pregnancy.

Frequently Asked Questions

What is the upper limit to participant capacity for this clinical experiment?

"Affirmative. Clinicaltrials.gov's information affirms that this clinical trial is presently recruiting participants, having been published on March 10th 2022 and revised most recently on April 5th 2022. The study requires 60 people to be recruited from one medical center." - Anonymous Online Contributor

Unverified Answer

Are there any remaining vacancies for participants in this clinical trial?

"As detailed on clinicaltrials.gov, this medical experiment is actively enlisting participants, with the first posting dating back to March 10th 2022 and most recent update occurring on April 5th of that same year." - Anonymous Online Contributor

Unverified Answer

What are the fundamental aims of this medical experiment?

"The purpose of this clinical trial, to be conducted over a 30-minute period post-feeding, is to evaluate infants' respiratory rate responses. Additional secondary outcomes include overall severity of illness score using the Neonatal Medical Index (ranging from 1 [least severe] to 5 [most severe]), infant's sex (female vs male), and degree of bronchopulmonary dysplasia (none, mild, moderate or severe)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.