Body Weight ChangesNCT01989871
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
A study testing Adjusted individual feeding in people with Body Weight Changes and Feeding and Eating Disorders of Childhood, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term. Read more about this study
- Who is it for?
- Ages 25 to 32 weeks
- Conditions the study is for
- Body Weight Changes, Feeding and Eating Disorders of Childhood, Breast Feeding
- What is being tested?
- Adjusted individual feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2015
- 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 25 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth at less than 32 weeks of gestation
Who cannot join
- High grade intraventricular hemorrhage (grade 3 or4)
- genetic syndrome
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan, 52621
Iris Morag, MD, +526479996, irismorag@gmail.com
Tzipi Strauss, MD, +526664446
About this study
Official title: Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm
The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term.
In the long term AIF will result in higher scores on the Griffith's developmental scales, decreasing parental anxiety and feeding disorders .
Read the detailed description
Preterm infants born at <32 weeks of gestation at our institute will qualify for this study. Recruitment will occur between day 7-14 of life after sever brain malformations or intraventricular bleeding will be ruled out. Randomization to control or intervention will be via sealed envelopes. In the control group - infants will be treated according to the common practice in the neonatal intensive care unit. Transition to oral feeding will occur at 33 wkks (breast feeding) and 34 wks (bottle feeding). Meals will be given every 3 hours, the amount will be written by the care giving physician and will be written as a strict number (i.e 30 ml every 3 hours) Parents in the intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them pace feeding. During the study parents in both groups will be interviewed every 14 days as for their satisfactions, anxieties, infants ability to cope. video typing during Kangaroo care at 32 and 35 wks as well as during feeding at 35 weeks will be done and evaluated. General movements assessment (neurodevelopment) will be done at 33 -35 weeks gestational age, as well as at 52 weeks. Alberta infant motor scales will be evaluated at 4 and 8 month corrected age,Automated Brain stem evoked Response (ABR) will be done at 33 wks for assessment of brain stem maturity, duration of hospitalization, weight gain per week at 33, 34 and 35 weeks will be calculated, age at full oral feeding will be noted. At the age of 6 month Griffith's developmental scales will be performed
- Conditions
- Body Weight Changes, Feeding and Eating Disorders of Childhood, Breast Feeding, Evoked Response Audiometry
- Being tested
- Adjusted individual feeding
- Keywords
- preterm, oral feeding, outcome
- Medical subject headings
- Body Weight Changes, Feeding and Eating Disorders of Childhood, Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusted individual feedingBehavioural
Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.
| Study group | Role | What they receive |
|---|---|---|
| protocol feeding | No intervention | Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount |
| Adjusted individual feeding | Experimental | Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs. Receives: Behavioral: Adjusted individual feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospitalization
length of hospitalization from admission to discharge, and length of stay beyond reaching 36 weeks corrected age , the time point at wich health infants are usually being discharged
Measured: between 36-40 weeks gestational age
Secondary outcomes (1)
age at reaching full oral feedings
the age at which no nasogastric tube was used
Measured: between 34-38 gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Iris Morag, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989871
- Sponsor's protocol ID
- SHEBA-12-9574-IM-CTIL
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm
- ClinicalTrials.gov ID
- NCT01989871
- Acronym / sponsor ID
- SHEBA-12-9574-IM-CTIL
- Conditions
- Body Weight Changes, Feeding and Eating Disorders of Childhood, Breast Feeding, Evoked Response Audiometry
- Keywords
- preterm, oral feeding, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- 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 authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term.
In the long term AIF will result in higher scores on the Griffith's developmental scales, decreasing parental anxiety and feeding disorders .
Detailed description
Preterm infants born at <32 weeks of gestation at our institute will qualify for this study. Recruitment will occur between day 7-14 of life after sever brain malformations or intraventricular bleeding will be ruled out. Randomization to control or intervention will be via sealed envelopes. In the control group - infants will be treated according to the common practice in the neonatal intensive care unit. Transition to oral feeding will occur at 33 wkks (breast feeding) and 34 wks (bottle feeding). Meals will be given every 3 hours, the amount will be written by the care giving physician and will be written as a strict number (i.e 30 ml every 3 hours) Parents in the intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them pace feeding. During the study parents in both groups will be interviewed every 14 days as for their satisfactions, anxieties, infants ability to cope. video typing during Kangaroo care at 32 and 35 wks as well as during feeding at 35 weeks will be done and evaluated. General movements assessment (neurodevelopment) will be done at 33 -35 weeks gestational age, as well as at 52 weeks. Alberta infant motor scales will be evaluated at 4 and 8 month corrected age,Automated Brain stem evoked Response (ABR) will be done at 33 wks for assessment of brain stem maturity, duration of hospitalization, weight gain per week at 33, 34 and 35 weeks will be calculated, age at full oral feeding will be noted. At the age of 6 month Griffith's developmental scales will be performed
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protocol feeding | No intervention | –Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount |
| Adjusted individual feeding | Experimental | Behavioral: Adjusted individual feedingFeeding every 2-4 hours, starting with que of hunger and finished upon infant signs. |
Who may qualify
- Ages
- 25 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- birth at less than 32 weeks of gestation
Key exclusion criteria (2 listed)
- High grade intraventricular hemorrhage (grade 3 or4)
- genetic syndrome
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 |
|---|---|---|
| Adjusted individual feedingFeeding every 2-4 hours, starting with ques of hunger and finished upon infant signs. | Behavioural | Adjusted individual feeding |
Primary outcome
length of hospitalization
Time frame: between 36-40 weeks gestational age
length of hospitalization from admission to discharge, and length of stay beyond reaching 36 weeks corrected age , the time point at wich health infants are usually being discharged
1 secondary outcome
age at reaching full oral feedings
Time frame: between 34-38 gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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.
Iris Morag, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjusted individual feeding in people with Body Weight Changes and Feeding and Eating Disorders of Childhood, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 2 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 21 Nov 2013. 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 Israel. 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?
Contact Iris Morag, MD (+526479996, irismorag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of hospitalization (time frame: between 36-40 weeks gestational age). 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 21 Nov 2013.