Assisted Exercise in Prematurity; Effects and Mechanisms

• ClinicalTrials.gov Identifier: NCT00580099
• Recruitment Status: Withdrawn
• First Posted: December 24, 2007
• Last Update Posted: January 25, 2021
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): University of California, Irvine

Study Description

Brief Summary:

Briefly our study is looking at the effects of 4 weeks of assisted exercise on the body composition and neurological/behavioral development of healthy growing premature infants enrolled between the ages of 30-33 weeks. It is a blinded study where the active group gets the exercise intervention and the control group is cuddled for the same amount of time -approximately 20 minutes. We get baseline data using muscle ultrasound, bone speed of sound and DEXA. We also get baseline blood samples to look at inflammatory mediators and growth hormone. Video of each subject is recorded an hour at two time points during the study to assess the babies for spontaneous activity. Nutritional intake information is collected daily and in the 4th week of the study assessments made for total energy expenditure using doubly labeled water. At this point in the study we repeat the ultrasounds and DEXA for comparison. Finally in the period just before discharge we do a complex neurological exam using the Brazelton NBAS assessment.

Condition or disease	Intervention/treatment	Phase
Growth; Development	Other: assisted exercise; Other: cuddle	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Assisted Exercise in Prematurity; Effects and Mechanisms
• Actual Study Start Date: February 2006
• Actual Primary Completion Date: February 2006
• Actual Study Completion Date: February 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 4 weeks of assisted exercise using passive range of motion on all major joints	Other: assisted exercise; 4 weeks of passive range of motion exercise
Active Comparator: 2; cuddle for 20 minutes	Other: cuddle; cuddle infant for 20 minutes

Outcome Measures

Primary Outcome Measures :

1. Body composition, bone mineralization, muscle mass, anthropometric measurements [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. spontaneous movement [ Time Frame: two time points ]
2. Neurological/behavioral status [ Time Frame: end of 4th week ]
3. Blood Sampling to measure IGF-1, GHBP, IL-1ra [ Time Frame: Baseline, week 2 and week 4 ]

Eligibility Criteria

• Ages Eligible for Study: 30 Weeks to 35 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Preterm infants born at post menstrual ages of 23-33 weeks gestation Enrollment occurs at post menstrual age of 30 to 35 weeks.if their projected stay based on standard clinical criteria is four weeks after enrollment
• Enrollment occurs at post menstrual age of 30 up to 35 weeks, if their projected stay based on standard clinical criteria is 4 weeks after enrollment.
• Birth weight appropriate for gestational age (AGA) using current CDC growth charts. AGA is defined as plus or minus 2 standard deviations above the mean or above the third percentile.
• Tolerating full enteral feeds at greater than or equal to 100kcal/kg/day

Exclusion Criteria:

• Evidence of chromosomal or other major genetic abnormalities
• Existence of current diseases or syndromes including:

central nervous system or other neurological abnormalities chronic lung disease of prematurity requiring chronic use of corticosteroids, musculoskeletal diseases

• positive infant toxicology screen(urine) for drugs or alcohol
• Both parents are under the age of 18 years
• Babies with tracheostomy
• Babies receiving ventilator assistance with breathing
• Babies receiving IV fluids

Contacts and Locations

Locations

United States, California

University of California, Irvine

Orange, California, United States, 92865

Sponsors and Collaborators

University of California, Irvine

Investigators

• Principal Investigator: Dan M Cooper, MD; University of California, Irvine

More Information

Publications of Results:

Ahmad I, Zaldivar F, Iwanaga K, Koeppel R, Grochow D, Nemet D, Waffarn F, Eliakim A, Leu SY, Cooper DM. Inflammatory and growth mediators in growing preterm infants. J Pediatr Endocrinol Metab. 2007 Mar;20(3):387-96.

Other Publications:

Gravem D, Lakes KD, Teran L, Rich J, Cooper D, Olshansky E. Maternal perceptions of infant exercise in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2009 Sep-Oct;38(5):527-33. doi: 10.1111/j.1552-6909.2009.01055.x.

• Responsible Party: University of California, Irvine
• ClinicalTrials.gov Identifier: NCT00580099
• Other Study ID Numbers: 2005-4797; NIH Grant R01NR009070
• First Posted: December 24, 2007
• Last Update Posted: January 25, 2021
• Last Verified: January 2021

Keywords provided by University of California, Irvine:

premature infant, body composition, total energy expenditure; inflammatory growth mediators

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications