Feeding; Difficult, NewbornNCT04812249
Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants
An observational study of Feeding; Difficult, Newborn and Pre-Term, run by Assiut University.
Trial summary
The aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Feeding; Difficult, Newborn, Pre-Term
- What is being tested?
- Clinical assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2021
- Phase
- Observational
- 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 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Newborns whose gestational age of < 37 weeks.
Who may be able to join
- A randomised sample of all newborns whose gestational age of < 37 weeks .
- infants who will be admitted to the NICU of Assiut University Children Hospital between 1 May and 31 October 2021.
Who cannot join
- known congenital and/or chromosomal diseases.
- death during hospitalisation, or transfer to another institution.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants: a Prospective Study at Neonatology Unit of Assiut University Children Hospital
The aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge.
Read the detailed description
It is widely acknowledged that pre-term infants frequently experience difficulties in attaining independent oral feeding, thus delaying the achievement of an adequate nutritional status and hospital discharge which - according to the American Academy of Pediatrics- requires the ability to feed exclusively by mouth(1-2) The development of oral feeding ability in pre-term infants is therefore a primary concern for neonatologists.
Because of the immaturity of their body functions and the occurrence of co-morbidities, pre-term infants generally require a period of enteral feeding before they acquire the coordinated sucking ability that allows sufficient milk intake for growth(3) Furthermore, infant sucking skills differ between bottle- and breastfeeding (4), and pre-term infants have been reported to show a weaker and less coordinated suck (5).
Few studies have investigated the timing and effect of co-morbidities on the achievement of independent oral skills. Jadcherla et al. (6) reported that infants born with a gestational age of < 28 weeks showed a significant delay in attaining the transition to oral feeding, but it has also been found that the occurrence of morbidities negatively correlates with postmenstrual age at the time of achieving oral feeding skills (6),(7-8).
- Conditions
- Feeding; Difficult, Newborn, Pre-Term
- Being tested
- Clinical assessment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
Clinical assessment and follow up of oral feeding ability
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean post-menstrual age in weeks at the time of starting and achieving full oral feeding will be evaluated
Statistical analysis will be made using SPSS version 12 software to assess the outcomes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Feeding; Difficult, NewbornStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khalaf Ali, Assiut University
- Investigators
- Mostafa Shafeek, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812249
- Sponsor's protocol ID
- Oral feeding in preterms
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dodrill P, Donovan T, Cleghorn G, McMahon S, Davies PS. Attainment of early feeding milestones in preterm neonates. J Perinatol. 2008 Aug;28(8):549-55. doi: 10.1038/jp.2008.56. Epub 2008 Jun 26.
PubMed 18580883American Academy of Pediatrics Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008 Nov;122(5):1119-26. doi: 10.1542/peds.2008-2174.
PubMed 18977994Maggio L, Costa S, Zecca C, Giordano L. Methods of enteral feeding in preterm infants. Early Hum Dev. 2012 May;88 Suppl 2:S31-3. doi: 10.1016/S0378-3782(12)70011-7.
PubMed 22633510Lau C, Geddes D, Mizuno K, Schaal B. The development of oral feeding skills in infants. Int J Pediatr. 2012;2012:572341. doi: 10.1155/2012/572341. Epub 2012 Nov 5. No abstract available.
PubMed 23193413Capilouto GJ, Cunningham T, Frederick E, Dupont-Versteegden E, Desai N, Butterfield TA. Comparison of tongue muscle characteristics of preterm and full term infants during nutritive and nonnutritive sucking. Infant Behav Dev. 2014 Aug;37(3):435-45. doi: 10.1016/j.infbeh.2014.05.010. Epub 2014 Jun 20.
PubMed 24956503Jadcherla SR, Wang M, Vijayapal AS, Leuthner SR. Impact of prematurity and co-morbidities on feeding milestones in neonates: a retrospective study. J Perinatol. 2010 Mar;30(3):201-8. doi: 10.1038/jp.2009.149. Epub 2009 Oct 8.
PubMed 19812589Van Nostrand SM, Bennett LN, Coraglio VJ, Guo R, Muraskas JK. Factors influencing independent oral feeding in preterm infants. J Neonatal Perinatal Med. 2015 May 18;8(1):15-21. doi: 10.3233/NPM-15814045.
PubMed 25766199Hwang YS, Ma MC, Tseng YM, Tsai WH. Associations among perinatal factors and age of achievement of full oral feeding in very preterm infants. Pediatr Neonatol. 2013 Oct;54(5):309-14. doi: 10.1016/j.pedneo.2013.03.013. Epub 2013 May 7.
PubMed 23660538
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants: a Prospective Study at Neonatology Unit of Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04812249
- Acronym / sponsor ID
- Oral feeding in preterms
- Conditions
- Feeding; Difficult, Newborn, Pre-Term
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Mar 2021 (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 aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge.
Detailed description
It is widely acknowledged that pre-term infants frequently experience difficulties in attaining independent oral feeding, thus delaying the achievement of an adequate nutritional status and hospital discharge which - according to the American Academy of Pediatrics- requires the ability to feed exclusively by mouth(1-2) The development of oral feeding ability in pre-term infants is therefore a primary concern for neonatologists.
Because of the immaturity of their body functions and the occurrence of co-morbidities, pre-term infants generally require a period of enteral feeding before they acquire the coordinated sucking ability that allows sufficient milk intake for growth(3) Furthermore, infant sucking skills differ between bottle- and breastfeeding (4), and pre-term infants have been reported to show a weaker and less coordinated suck (5).
Few studies have investigated the timing and effect of co-morbidities on the achievement of independent oral skills. Jadcherla et al. (6) reported that infants born with a gestational age of < 28 weeks showed a significant delay in attaining the transition to oral feeding, but it has also been found that the occurrence of morbidities negatively correlates with postmenstrual age at the time of achieving oral feeding skills (6),(7-8).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns whose gestational age of < 37 weeks.
Key inclusion criteria (2 listed)
- A randomised sample of all newborns whose gestational age of < 37 weeks .
- infants who will be admitted to the NICU of Assiut University Children Hospital between 1 May and 31 October 2021.
Key exclusion criteria (2 listed)
- known congenital and/or chromosomal diseases.
- death during hospitalisation, or transfer to another institution.
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 |
|---|---|---|
| Clinical assessmentClinical assessment and follow up of oral feeding ability | Other | – |
Primary outcome
The mean post-menstrual age in weeks at the time of starting and achieving full oral feeding will be evaluated
Time frame: Baseline
Statistical analysis will be made using SPSS version 12 software to assess the outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Background: PubMed 18580883Dodrill P, Donovan T, Cleghorn G, McMahon S, Davies PS. Attainment of early feeding milestones in preterm neonates. J Perinatol. 2008 Aug;28(8):549-55. doi: 10.1038/jp.2008.56. Epub 2008 Jun 26.
- Background: PubMed 18977994American Academy of Pediatrics Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008 Nov;122(5):1119-26. doi: 10.1542/peds.2008-2174.
- Background: PubMed 22633510Maggio L, Costa S, Zecca C, Giordano L. Methods of enteral feeding in preterm infants. Early Hum Dev. 2012 May;88 Suppl 2:S31-3. doi: 10.1016/S0378-3782(12)70011-7.
- Background: PubMed 23193413Lau C, Geddes D, Mizuno K, Schaal B. The development of oral feeding skills in infants. Int J Pediatr. 2012;2012:572341. doi: 10.1155/2012/572341. Epub 2012 Nov 5. No abstract available.
- Background: PubMed 24956503Capilouto GJ, Cunningham T, Frederick E, Dupont-Versteegden E, Desai N, Butterfield TA. Comparison of tongue muscle characteristics of preterm and full term infants during nutritive and nonnutritive sucking. Infant Behav Dev. 2014 Aug;37(3):435-45. doi: 10.1016/j.infbeh.2014.05.010. Epub 2014 Jun 20.
- Background: PubMed 19812589Jadcherla SR, Wang M, Vijayapal AS, Leuthner SR. Impact of prematurity and co-morbidities on feeding milestones in neonates: a retrospective study. J Perinatol. 2010 Mar;30(3):201-8. doi: 10.1038/jp.2009.149. Epub 2009 Oct 8.
- Background: PubMed 25766199Van Nostrand SM, Bennett LN, Coraglio VJ, Guo R, Muraskas JK. Factors influencing independent oral feeding in preterm infants. J Neonatal Perinatal Med. 2015 May 18;8(1):15-21. doi: 10.3233/NPM-15814045.
- Background: PubMed 23660538Hwang YS, Ma MC, Tseng YM, Tsai WH. Associations among perinatal factors and age of achievement of full oral feeding in very preterm infants. Pediatr Neonatol. 2013 Oct;54(5):309-14. doi: 10.1016/j.pedneo.2013.03.013. Epub 2013 May 7.
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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.
Mostafa Shafeek study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding; Difficult, Newborn and Pre-Term, run by Assiut University.
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 2 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Mohammed Khalaf Ali (+201002424743, mohamed.khalaf119911@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean post-menstrual age in weeks at the time of starting and achieving full oral feeding will be evaluated (time frame: Baseline). 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 NCT04812249, which also lists 8 linked publications.
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 25 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.