Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03354988 |
| Other study ID # |
FMASU 2015 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
August 2018 |
Study information
| Verified date |
May 2018 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of this study is to assess whether physical activity programs in preterm
infants improve bone mineralization as well as growth and reduce the risk of fractures.
The secondary aim is to include other potential benefits in terms of length of hospital stay,
weaning from mechanical ventilation, feeding tolerance and adverse events
Description:
This is a prospective randomized controlled clinical trial that will be conducted on 36 VLBW
preterm infants admitted to the neonatal intensive care unit (NICU) - Ain Shams University
METHODS:
All the newborns included in the study will be subjected to the following:
1. Comprehensive history taking including:
- Antenatal history: Maternal age, maternal diseases, maternal diabetic control,
maternal infection (STORCH infection), maternal medication during this pregnancy,
and last menstrual period.
- Natal history: Gestational age, neonatal sex and mode of delivery.
- Postnatal history: Respiratory distress and cyanosis.
- Family history: Consanguinity, congenital anomalies, previous abortion, sibling
death, and still birth.
2. Thorough clinical examination with particular emphasis on:
- Assessment of Apgar scores at 1 and 5 minutes
- Assessment of gestational age based on last menstrual period and confirmed by
ultrasonography in early pregnancy if possible and Ballard scores
- Complete examination including cardiac, chest, abdominal, and neurological
examination.
3. Sample size calculation and Randomization:
The sample size was calculated using power and sample size calculation program and was
based on the previously reported intervention changes in Bone mineral density (BMD)
following assisted exercise. A mean difference of 5.3 mg cm2 between the groups, with a
standard deviation of 5.6 mg cm2 was used, based on the study by Considering a 0.05
significance level and power equal to 80%, an n of 19 patients per group was determined.
Patients who will meet the inclusion criteria will be randomized into the physical
exercise (n=18) and control (n=18) groups. Randomization will be made by birth order;
the first born preterm infant will be recruited to the exercise group, the second to the
control group, etc.
4. Standard neonatal care:
- Babies admitted to NICU bathed, placed in incubator, attached to monitor.
- Cannula inserted, IV fluids is started (Dexstrose10%) and IV antibiotics.
- If there is respiratory distress: O2 or ventilation is started, usually feeds are
delayed to day 2 or day 3 (or even later) according the severity of condition
(clinical decision according to the attending neonatologist).
- If no distress and the baby is well: trophic feeds is started (10ml/kg/day milk),
feeds is increased in 10-20ml/kg/day according to baby tolerance, and the condition
of the baby (clinical decision according to the attending neonatologist), IV fluids
are reduced gradually.
5. Exercise protocol:
The exercise protocol was designed for Infants in treatment and control groups received
well defined interventions applied by the same trained occupational therapist, described
as follows:
For the exercise group, systematic physical activity programs consisting of
range-of-motion exercises with gentle compression, extension and flexion of all joints
of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower
extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity
was about 10 min a day and was carried out 5 times per week for 4 weeks. This program
was started after 1 week of birth. Physical activity continued until discharge from
hospital.
Because tactile stimulation might have influenced growth and development, control
subjects had a daily interactive period of holding and stroking but no range-of-motion
activity. The time schedule of each activity was the same as the exercise group. Other
routine care activities such as bathing (every day) and kangaroo care (30 minutes/day),
will be done for both the control and exercise group subjects according to the neonatal
intensive care unit (NICU) recommendations, however, without movement and standardized
articular compression.
6. Laboratory investigation:
- Complete blood count with differential leucocytic count.
- Serum calcium concentration.
- Serum phosphorous concentration.
- Serum magnesium concentration.
- Serum alkaline phosphates concentration.
- Serum Alanine Aminotransferase (ALT).
- Serum carboxy-terminal cross linked telopeptides of type 1 collagen (CTX).
- Urinary calcium/phosphorous ratio.
All the previous investigations will be done before at after the end of the exercise
protocol for patients and control groups.
7. Bone mineralization will be assessed by measured by dual- energy x- ray absorptiometry
(DEXA) :
DEXA evaluates body composition (total body will be done after the end of the exercise
protocol for patients and control groups by measuring:
- Bone mineral Content (BMC, mg),
- Bone Mineral Density (BMD, mg/ cm2),
- Bone area (BA/ cm2),
- Lean mass (LM, g) and
- Fat mass (g).
8. Ethical Considerations:
Collected data will be used for study purpose only. The mothers of the newborns under study
will be informed about the purpose of the study and the plan of work before agreeing to
participate. They will be provided informed consent before the testing began. Study protocol
will be presented to and approved by the Ethical Committee of the Scientific Research-Ain
Shams University.
