Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06226051
Other study ID # 2023-0931
Secondary ID A536757SMPH/PEDI
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date January 2027

Study information

Verified date May 2024
Source University of Wisconsin, Madison
Contact Whitley Hulse, MD
Phone 608-620-4924
Email whulse@wisc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development. Participants will: - have body growth measurements collected using the PEAPOD device - have nutritional information collected, and - be followed for neurodevelopmental outcomes Participants can expect to be in the study for 36 months.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date January 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 22 Weeks to 32 Weeks
Eligibility Neonate Inclusion Criteria: - Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d) Neonate Exclusion Criteria: - Known genetic condition that impacts neurodevelopmental outcomes or brain structure development - Multiple major congenital anomalies - Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA - Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD Birthing Parent Inclusion Criteria: - Birthing parent must speak English or Spanish due to consent documents - Able to understand and willing to sign a written informed consent document - Primary caregiver of a neonate who is eligible to participate in the study - Agrees to enroll neonate into the study - Willing to comply with all study procedures and be available for the duration of the study - Age 15 or older Birthing Parent Exclusion Criteria: - Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody - Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy - Not suitable for study participation due to other reasons at the discretion of the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PEAPOD Infant Body Composition measuring device
PEAPOD is a device to that collects body composition measurements.

Locations

Country Name City State
United States Meriter Hospital, Inc. Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Meriter Hospital, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the correlation between nutritional intake over the first two weeks of life and the percent increase in fat-free mass measured by the PEAPOD The least absolute shrinkage and selection operator technique will be utilized to determine whether fat intake predicts a percent increase in fat-free mass Birth to 2 weeks
Primary To evaluate the correlation between higher nutritional intake in the first 2 weeks of life and the General Movement Assessment (GMA) and/or the Bayley Scales of Infant and Toddler Developmental Scores (Bayley) The least absolute shrinkage and selection operator technique will be utilized to determine whether higher nutritional intake predicts Bayley cognitive scores Birth to 36 months
Primary To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores. The least absolute shrinkage and selection operator technique will be utilized to determine whether the percent increase in fat-free mass predicts GMA scores and Bayley scores. Birth to 36 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Active, not recruiting NCT03655639 - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT03337659 - A Cluster Randomized Controlled Trial of FICare at 18 Months N/A
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Completed NCT03251729 - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix Phase 4
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
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
Not yet recruiting NCT02880696 - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates N/A
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT02913495 - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Phase 4
Completed NCT02879799 - Family Integrated Care (FICare) in Level II NICUs N/A
Completed NCT02661360 - Effects of Swaddling on Infants During Feeding N/A
Completed NCT02743572 - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants N/A
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Completed NCT01163188 - Social Adjustment and Quality of Life After Very Preterm Birth N/A
Terminated NCT00675753 - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families N/A
Completed NCT00271115 - Kangaroo Holding and Maternal Stress N/A