Observational Study Exploring the Timing of Postnatal Neonate Weight Measurements (WEIGHT)
Study Overview
Status
Conditions
Detailed Description
The impact of even 1 formula supplementation can have detrimental effects on both mum and baby; decreased eagerness to breastfeed - leading to low milk supply, can trigger allergic sensitisation, and loss of confidence for the mother in breastfeeding. Maternal mental health within the first week of the postnatal period can be a turbulent time with increased hormones levels and adapting to a new normal. Ensuring good well-being of mothers is incredibly important to ensure the mother is able to bond well with her baby - a healthy loving relationship between parents and babies is integral to the brain development of the baby. Exposure in the first 1 year of the baby's life is the most integral part in helping to shape their emotional, cognitive and social capabilities (HM Government, 2021). This research project is of local and national importance for patient and parent care to improve long term health benefits of protecting breastfeeding journeys.
The main aim of the study is to collect data on the weight of neonates in the first 5 days of life.
Women will be consented in the first 24 hours following the birth of their baby if they fit the criteria. Baseline information will be collected:
- Time & Date of birth
- Type of birth
- Weight at birth
- Any medical risk factors i.e diabetes, high blood pressure etc
- Feeding type (breastfeeding, formula, or both)
- Gestation at birth
A maternity support worker will be tasked with weighing all the babies as near to their birth times possible and all data will be collected and logged. Following this the data will be sorted and correlated to look for any trends:
- What day had the biggest weight loss
- When did the weight begin to increase
- Were bigger weight losses linked with a certain type of birth or medical condition that the patient had
- Did the gestational age when the baby was born have any link with greater weight loss
The end of the study will be defined as the date when the last baby entered into the study had had their final weight completed at the end of the 5-day period. This also included the collection of all weight data for the 5-day duration and any necessary data validation and quality checks. Following the final weight measurement, the data will be prepared for analysis to examine the trends in weight loss/gain over the study period. The results will be analysed and disseminated as outlined. Following on from this pilot study, it is hoped that a larger national study will take place to continue to collect weight loss data and help define the normal weight loss/gain which neonates experience in the first few days of life.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stephanie Roberson
- Phone Number: 01473 703052
- Email: stephanie.roberson@esneft.nhs.uk
Study Contact Backup
- Name: Hannah Stansfield
- Email: R&D@esneft.nhs.uk
Study Locations
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Ipswich, United Kingdom
- Recruiting
- East Suffolk and North Essex NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient who births their baby within the timeframe of the data collection will be eligible to join the study
Exclusion Criteria:
- Patients who birth their babies outside of the range as above.
- Babies who are admitted to the neonatal unit from birth.
- Mothers less than 16 years old
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Natural birth cohort
Pregnant women who have given birth naturally.
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Caesarean cohort
Pregnant women who give birth via caesarean section
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To find out when the best day to weigh a newborn baby is between birth and 5 days.
Time Frame: Between birth and 5 days old of newborn baby.
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This pilot sample with give us a baseline of data and help to calculate the data size needed to adequately power a larger multi-centre study to provide evidence to inform the best day/days to weight babies after birth and allow for the development phase of the production of individual weight loss charts for neonates.
Babies will be weighed from day of birth up until 5 days old (5 separate weights)
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Between birth and 5 days old of newborn baby.
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie Roberson, East Suffolk and North Essex NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22/100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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