PrematureNCT04283682
Intervention Facilitates Oral Feeding in Premature Infants
A study testing Early skin-to-skin combined with breast-feeding in people with Premature, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Premature
- What is being tested?
- Early skin-to-skin combined with breast-feeding
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2020to 30 May 2022
- 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age ≤30 weeks
- birth weight < 1500g
- age of admission <72 hours
- no congenital malformation
Who cannot join
- OI > 40
- mother has trouble in communicating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants
Read the detailed description
This study is conducted at the level 3 NICU of the Children's Hospital of Fudan University, Shanghai, People's Republic of China, a tertiary medical center. Infants admitted to the NICU are all outborn infants.
The study is approved by the Ethics Committee of the Children's Hospital of Fudan University. Signed parental consent is obtained before participants'entry into the study. The RCT is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding.
The recruited infants are assigned to intervention group and control group.
Data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. One-way analysis of variance and Fisher exact test is used to compare infants' baseline characteristics among the two groups. All statistical analyses are conducted using SPSS. A p value of less than 0.05 is regarded as statistically significant.
- Conditions
- Premature
- Being tested
- Early skin-to-skin combined with breast-feeding
- Keywords
- Skin Contact, bresatfeeding, premature, oral feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early skin-to-skin combined with breast-feedingBehavioural
Premature infants in the intervention group have access to skin-to-skin once a day for 1 hour at least once no ventilation support needed. During the skin-to-skin period,the breastfeeding is encouraged for about 5-10 minutes. The whole intervention stop until the baby achieve the full oral feeding.
| Study group | Role | What they receive |
|---|---|---|
| standard group | No intervention | Feeding procedures follow clinical nursing practices |
| intervention group | Experimental | At appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding Receives: Behavioral: Early skin-to-skin combined with breast-feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition time from the initiation oral feeding to full oral feeding
Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.
Measured: During the procedure
Secondary outcomes (1)
Exclusive breastfeeding at discharge
Exclusive breastfeeding at discharge is defined as through breastfeeding without bottle feeding at discharge.On the day of discharge, newborns are weighed before regular feeding and then breastfed by their mothers. After breastfeeding, the baby is weighed again and the amount of breast milk obtained by sucking the mother's breast is assessed. If the two weight subtractions are greater than or equal to the amount required for once bottle feeding, the baby is considered exclusively breastfeding at discharge.
Measured: During the hospitalization, an average of 2 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start8 Apr 2020
- Primary completion1 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ling li Li, Study chair, Wanyuan Road 399,Minhang District, Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283682
- Sponsor's protocol ID
- EKYY-2019-295
- Status last verified
- Dec 2022
- First submitted
- 18 Feb 2020
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. Early skin contact combined with mother's breastfeeding to shorten the process of premature infants </= 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.
PubMed 34535164
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Skin Contact Combined With Breastfeeding on Oral Feeding in Premature Infants ≤30 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT04283682
- Acronym / sponsor ID
- EKYY-2019-295
- Conditions
- Premature
- Keywords
- Skin Contact, bresatfeeding, premature, oral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 25 Feb 2020 (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.
Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants
Detailed description
This study is conducted at the level 3 NICU of the Children's Hospital of Fudan University, Shanghai, People's Republic of China, a tertiary medical center. Infants admitted to the NICU are all outborn infants.
The study is approved by the Ethics Committee of the Children's Hospital of Fudan University. Signed parental consent is obtained before participants'entry into the study. The RCT is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding.
The recruited infants are assigned to intervention group and control group.
Data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. One-way analysis of variance and Fisher exact test is used to compare infants' baseline characteristics among the two groups. All statistical analyses are conducted using SPSS. A p value of less than 0.05 is regarded as statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | No intervention | –Feeding procedures follow clinical nursing practices |
| intervention group | Experimental | Behavioral: Early skin-to-skin combined with breast-feedingAt appropriate time to invite mothers of premature infants into the NICU for skin-to-skin and breastfeeding |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- gestational age ≤30 weeks
- birth weight < 1500g
- age of admission <72 hours
- no congenital malformation
Key exclusion criteria (2 listed)
- OI > 40
- mother has trouble in communicating
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 |
|---|---|---|
| Early skin-to-skin combined with breast-feedingPremature infants in the intervention group have access to skin-to-skin once a day for 1 hour at least once no ventilation support needed. During the skin-to-skin period,the breastfeeding is encouraged for about 5-10 minutes. The whole intervention stop until the baby achieve the full oral feeding. | Behavioural | intervention group |
Primary outcome
Transition time from the initiation oral feeding to full oral feeding
Time frame: During the procedure
Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.
1 secondary outcome
Exclusive breastfeeding at discharge
Time frame: During the hospitalization, an average of 2 to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 34535164Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. Early skin contact combined with mother's breastfeeding to shorten the process of premature infants </= 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.
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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.
ling li Li study chair
Wanyuan Road 399,Minhang District, Shanghai,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early skin-to-skin combined with breast-feeding in people with Premature, run by Children's Hospital of Fudan University at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 8 Dec 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transition time from the initiation oral feeding to full oral feeding (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283682, which also lists 1 linked publication.
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 8 Dec 2022.