Osteopenia PrematurityNCT03354988
Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
A study testing Physical exercise group in people with Osteopenia Prematurity, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Osteopenia Prematurity
- What is being tested?
- Physical exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants (gestational age <37 completed weeks) who did not receive physical therapy for any indication other than osteopenia of prematurity (e.g. severe contractures);
- Birth weight ≤ 1.500gm;
- Body size appropriate for gestational age;
- Postnatal age of ≥1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity;
- Tolerating enteral feeds of either fortified breast milk or preterm formula at or above 100 kcal/kg/d.
- Not requiring oxygen or mechanical ventilation at the start of the exercise protocol.
Who cannot join
- Congenital or acquired anomaly of the Respiratory tract (i.e., diaphragmatic hernia, pulmonary hypoplasia, pulmonary sequestration, bronchogenic cysts);
- Other major congenital anomalies (congenital heart disease, neural tube defect, omphalocele, trisomy, etc.);
- Premature infants diagnosed with serious periventricular hemorrhaging (degrees 3 and 4) or serious sepsis;
- Use of medications (diuretics, methylxanthines and corticosteroids); Infants who had received major surgery within the first two weeks of life
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- Conditions
- Osteopenia Prematurity
- Being tested
- Physical exercise group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise groupOther
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
Control groupOther
Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control
| Study group | Role | What they receive |
|---|---|---|
| physical exercise group | Active comparator | For the exercise group, Intervention by doing physical exercise. 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. Receives: Other: Physical exercise group |
| Control group | Other | Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum calcium
mg/dL
Measured: 2 weeks
serum PO4
mg/dL
Measured: 2 weeks
serum magnesium
mg/dL
Measured: 2 weeks
ALP
IU/L
Measured: 2 weeks
CTX
pg/mL
Measured: 2 weeks
Whole body BMD
mg/cm2
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia PrematurityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ali El-Farrash, Ain Shams University
- Investigators
- rania elfarrash, assprofessor, Principal investigator, Ain Shams univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354988
- Sponsor's protocol ID
- FMASU 2015
- Status last verified
- May 2018
- First submitted
- 19 Mar 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Assisted Exercise on Musculoskeletal System and Growth in Preterm Infants
- ClinicalTrials.gov ID
- NCT03354988
- Acronym / sponsor ID
- FMASU 2015
- Conditions
- Osteopenia Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical exercise group | Active comparator | Other: Physical exercise groupFor the exercise group, Intervention by doing physical exercise. 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. |
| Control group | Other | Other: Control groupOther routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm infants (gestational age <37 completed weeks) who did not receive physical therapy for any indication other than osteopenia of prematurity (e.g. severe contractures);
- Birth weight ≤ 1.500gm;
- Body size appropriate for gestational age;
- Postnatal age of ≥1 week with medically stable condition and favorable evolution that is presenting no associated diseases besides prematurity;
- Tolerating enteral feeds of either fortified breast milk or preterm formula at or above 100 kcal/kg/d.
Key exclusion criteria (4 listed)
- Congenital or acquired anomaly of the Respiratory tract (i.e., diaphragmatic hernia, pulmonary hypoplasia, pulmonary sequestration, bronchogenic cysts);
- Other major congenital anomalies (congenital heart disease, neural tube defect, omphalocele, trisomy, etc.);
- Premature infants diagnosed with serious periventricular hemorrhaging (degrees 3 and 4) or serious sepsis;
- Use of medications (diuretics, methylxanthines and corticosteroids); Infants who had received major surgery within the first two weeks of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise groupFor 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 | Other | physical exercise group |
| Control groupOther routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control | Other | Control group |
Primary outcome
serum calcium
Time frame: 2 weeks
mg/dL
serum PO4
Time frame: 2 weeks
mg/dL
serum magnesium
Time frame: 2 weeks
mg/dL
ALP
Time frame: 2 weeks
IU/L
CTX
Time frame: 2 weeks
pg/mL
Whole body BMD
Time frame: 2 weeks
mg/cm2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Bone mineralization in preterm infantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteopenia Prematurity
Not yet recruiting
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Vitamin D Deficiency, Osteopenia of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rania elfarrash, assprofessor principal investigator
Ain Shams univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise group in people with Osteopenia Prematurity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum calcium (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.